Guidance on Screening and Symptomatic Breast Imaging (Second Edition)
Ref No: BFCR(03)2
Guidance on Screening and Symptomatic Breast Imaging
Second Edition
Board of Faculty of Clinical Radiology
The Royal College of Radiologists
The Royal College of Radiologists
38 Portland Place
London W1B 1JQ
Telephone 020 7636 4432
Fax 020 7323 3100
Citation details:
Board of the Faculty of Clinical Radiology
The Royal College of Radiologists (2003)
Guidance on Screening and Symptomatic Breast Imaging
Royal College of Radiologists, London
Email: enquiries@rcr.ac.uk
ISBN 1 872599 85 0
RCR Ref No BFCR(03)2
© The Royal College of Radiologists, June 2003
This publication is copyright under the Berne Convention and the
International Copyright Convention.
All rights reserved.
This booklet was prepared and published on behalf of The Royal College of Radiologists (RCR). Whilst every attempt has been made to provide accurate and useful information, neither the RCR, the members and Fellows of the RCR nor other persons contributing to the formation of the booklet make any warranty, express or implied, with regard to accuracy, omissions and usefulness of the information contained herein. Furthermore, the same parties do not assume any liability with respect to the use, or subsequent damages resulting from the use of the information contained in the booklet.
Please note: A statement by the Dean, Dr Gill Markham, on a possible discrepancy between advice contained within the Department of Health Cancer Care Standards for Breast Radiologists, and the College document BFCR(03)2 Guidance on Screening and Symptomatic Breast Imaging, 2nd edition,can be found
here
Contents
Foreword
1 Introduction
1.1 Background
1.2 Summary of guidelines
2 Organisation of Breast Imaging Services
2.1 Symptomatic breast imaging services
2.2 Population breast cancer screening of asymptomatic women
3 Breast Imaging Protocols
3.1 Symptomatic breast imaging
3.2 Mammographic screening of patients at increased risk of breast cancer
3.3 The use of imaging in the follow-up of patients with breast cancer
3.4 Imaging of women with breast implants
3.5 Image-guided breast interventional procedures
3.6 Supplementary imaging techniques
4 Professional Standards
4.1 Radiologists involved in symptomatic breast imaging
4.2 Radiologists involved in the NHSBSP
5 Equipment
5.1 Imaging equipment sufficient for satisfactory diagnostic images
5.2 Mammography equipment for symptomatic breast imaging and breast screening assessment
5.3 Ultrasound equipment for breast imaging
6 Radiation Risks in Mammography
Appendix A: Genetic Breast Cancer: Criteria to Establish Those at Moderate Risk
Appendix B: Breast Radiologist Professional Standards
References
Foreword
Breast imaging is in increasing demand as a result of recommended
changes in the provision of cancer services in the National Health Service and
the widespread development of specialist breast clinics around the UK. This
guidance has been produced by a working party of The Royal College of
Radiologists' Breast Group. It updates the first edition of the guidance
published in 1999 (BFCR(99)12), which is now withdrawn.
The document is provided for radiologists and other members of breast
teams providing diagnostic, treatment and follow-up services for patients with symptomatic
breast problems. Guidance on the role of imaging in breast cancer screening is
also included. Wherever possible this guidance is evidence-based but if definitive evidence does not
exist, it is based on currently perceived best practice.
I am extremely grateful to the following members of the working party
and in particular the Chairman, Dr Peter Britton, for drafting this document:
Dr Sue Barter, Bedford
Dr Peter Britton, Cambridge
Dr Ros Given-Wilson, London
Dr Matthew Wallis, Coventry
I would like to thank the compilers (with Dr Wallis) of the first
edition of the guidance:
Professor Stuart Field, Canterbury
Dr Caroline Boggis, Manchester
Dr Hilary Dobson, Glasgow
Dr William Teh, Northwick Park
Dr Robin Wilson, Nottingham
I would also like to acknowledge the assistance received from the other members of the RCR Breast Group Executive Committee, the many other members of the group who have commented, as well as Dr Ken Young of the National Coordinating Centre for the Physics of Mammography, Guildford, Surrey, for his invaluable help on the section covering radiation risks in mammography.
Dr Mike Dean
Dean
Faculty of Clinical Radiology
1 Introduction
1.1 Background
The majority of women presenting with symptomatic breast disease first consult with their general practitioner (GP). Most of these women can be managed, at least initially, by their GP and guidelines regarding those patients who should be referred for specialist opinion have been published by the National Health Service Breast Screening Programme (NHSBSP) and The Royal College of Radiologists (RCR).1,2 The resultant guidelines, which are briefly summarised below, are not intended to be a definitive statement on how breast disorders should be managed in primary care. They are intended to aid discussions when drawing up locally produced guidelines. It is essential that GPs are involved in this process.
1.1.1 Women who can be managed at least initially by their GP:
- young women with tender, lumpy breasts and older women with symmetrical nodularity provided that they have no localised abnormality;
- women with minor and moderate degrees of breast pain who do not have a discrete palpable lesion;
- women under the age of 50 years who have nipple discharge that is from more than one duct or is intermittent and is neither bloodstained nor troublesome.
1.1.2 Conditions
that require referral to a specialist breast clinic. Patients requiring
referral should be seen in a multi-disciplinary breast clinic where triple assessment
(clinical assessment, imaging and needle cytology/histology) is available;
direct access from GPs for imaging alone is not recommended.
Lump:
- any new discrete lump;
- new lump in pre-existing nodularity;
- asymmetrical nodularity that persists at review after menstruation;
- abscess;
- cyst persistently refilling or recurrent cyst (if the patient has recurrent multiple cysts, and the GP has the necessary skills, then aspiration is acceptable).
Pain:
- if associated with a lump;
- intractable pain not responding to reassurance, simple measures such as wearing a well-supporting bra, and common drugs;
- unilateral persistent pain in post-menopausal women.
Nipple
discharge:
- all women aged 50 years and over;
- women under 50 years of age with bilateral discharge sufficient to stain clothes, blood-stained discharge or persistent discharge from a single duct.
Nipple
distortion, nipple eczema
Change in skin contour
Family history
Request for assessment by a woman with a strong family history of breast cancer is best dealt with under the direct supervision of a clinician with a special interest (see Appendix A).
1.2 Summary of guidelines
1.2.1 Background
1.2.1.1 Guidance on the
provision and quality of services for imaging in breast cancer screening are
already established through the quality assurance structure integral to the
NHSBSP. The provision of breast cancer screening for women aged 50 years and
over as part of the National Health Service (NHS), with the aim of reducing
mortality from this disease, is fully endorsed. However, there is a need to
ensure that breast imaging services for patients with symptomatic breast
problems are provided appropriately and to the same high quality standards as
apply in the NHSBSP.
1.2.1.2 The report to the Chief Medical Officers of England and Wales A Policy Framework for Commissioning Cancer Services: Guidance for Purchasers and Providers of Cancer Services 3 identifies the need for multidisciplinary teams for cancer diagnosis and care (Calman-Hine Report). This report emphasises the importance of a patient-centred and holistic approach to breast care from referral through diagnosis and assessment to treatment and palliative care. Implementation of the Calman-Hine recommendations involves the establishment of specialist breast cancer units linked to Cancer Centres; breast cancer units are required to treat a minimum of 100 new cases of breast cancer per annum (EL(96)15).4
1.2.1.3 Key themes in the strategy are:
- development of multidisciplinary teams, including those who provide imaging services;
- adherence to agreed diagnostic and treatment protocols;
- development of local guidelines on referral practice;
- carrying out clinical audit;
- participation in continuing medical education (CME).
1.2.1.4 This guidance takes into account the recommendations for symptomatic breast services published by the Breast Surgeons Group of the British Association of Surgical Oncology 5 and the British Breast Group 6 and also complements the Quality Assurance Guidelines for Radiologists in Breast Cancer Screening published by the NHSBSP and endorsed by the RCR.7 Comprehensive evidence-based guidance for purchasers on the provision of breast cancer services has been published by the NHS Executive in Guidance for Purchasers: Improving Outcomes in Breast Cancer. 8,9
1.2.1.5 With this background, the purpose of Guidance on Screening and Symptomatic Breast Imaging is to provide a framework on which radiologists and breast teams can base the provision of breast imaging services.
1.2.2 Guidance
evidence
The guidance
uses a three-point
grading system to identify the quality of the published evidence on which the
guidelines are based. The grading system is similar to that used in the Guidance for Purchasers: Improving Outcomes in Breast Cancer - The Research Evidence 9 which in itself has been adapted from the Clinical Outcomes Group categories of evidence for use in the writing of clinical practice guidelines.10
1.2.2.1 The grading systems
for the recommendations
Grade A
Based on evidence obtained from at least one randomised controlled trial or meta-analysis of relevant randomised controlled trials.
Grade B
Based on evidence obtained from at least one prospective study with a comparison group (non-randomised controlled trial or good observation study) and/or well-designed retrospective/cross-sectional studies.
Grade C
Based on evidence from reports of expert committees, the opinions of professional bodies and/or clinical experiences of respected authorities. Although there is lack of direct clinical studies, Grade C recommendation is based on what is regarded as good clinical practice at the present time.
1.2.3 Summary of
guidelines
| Guidelines |
Grade of recommendation
|
| Patients with symptomatic breast disease who have conditions that require referral, who may or may not require imaging, should be referred to a multidisciplinary Specialist Breast Clinic. |
C
|
| Imaging of symptomatic disease, which requires specialist referral, should only be performed as a part of triple assessment (clinical examination, imaging and needle biopsy [fine needle or core biopsy]). |
B
|
Mammography is the initial imaging modality of choice in symptomatic
patients over 35 years of age. |
B
|
| Ultrasound is the imaging modality of choice in symptomatic patients under 35 years of age. Mammography is NOT recommended unless there is a high clinical or ultrasound suspicion of breast cancer. |
B
|
| Asymptomatic women of 50 years of age or over should participate in the NHSBSP. |
A
|
Asymptomatic women under 50 years of age at high risk of developing breast cancers (e.g. with a strong family history) should have their risks determined in a Specialist Breast Clinic before either annual or biennial mammographic screening is performed following agreed protocols. |
C
|
| Asymptomatic women under 50 years of age receiving hormone replacement therapy (HRT) for more than five years have only a small increased risk of breast cancer and routine mammographic screening is not recommended for this reason alone. |
B
|
| Base-line mammography prior to commencing HRT is not recommended. |
C |
| Radiologists involved in breast imaging (both NHS screening and symptomatic) should have agreed professional standards and training. |
C
|
| Equipment used in breast imaging should satisfy the technical and quality requirements laid down by the NHSBSP. |
C
|
2 Organisation of Breast Imaging Services
2.1 Symptomatic breast imaging services
Diagnosis of breast disease should occur in a multidisciplinary setting using the principles of triple assessment (clinical assessment, imaging and needle cytology/histology). 11-18 This is best achieved in designated specialist breast clinics in which both radiologists and surgeons work closely together. 19-24 Direct access from GPs for breast imaging alone is not recommended.
These clinics
should:
- provide rapid patient access with measures to identify and prioritise those women with a higher suspicion of malignancy;
- be organised to ensure that, where possible, all necessary diagnostic procedures are carried out at the initial clinic visit (where this is not achievable imaging should be performed and reported within five working days);
- where practical, imaging should precede any needle aspiration or biopsy procedures.
Imaging should
be performed only where there is a clear clinical indication to do so.
Inappropriate requests should be monitored and subjected to audit.
2.2 Population breast cancer screening of asymptomatic women
Guidance for radiologists on breast cancer screening has been previously published by the NHSBSP,7 and the issue of informed consent has been discussed by the General Medical Council. 25
2.2.1 General
principles
- The technical quality of all screening mammography should be to the standards required by the NHSBSP.
- Radiographers performing screening mammography should hold, or be training for, the College of Radiographers Postgraduate Award in Mammography Practice.
- Screening mammography should be interpreted by radiologists who satisfy the professional standards required for radiologists involved in the NHSBSP.
- Ultrasound is not an effective imaging method for routine screening. 26
- Screening, wherever performed, should always include formally agreed mechanisms for referral, without delay, of women with screen-detected abnormalities to a specialist breast team.
- The examination should be preceded (or accompanied) by information detailing the risks, benefits and imperfections of screening mammography.
2.2.2 Mammographic
screening of women of 50 years and over
There is unequivocal evidence from randomised controlled trials that population screening of women between the ages of 50 and 65 years by mammography alone can, by early detection, reduce mortality from breast cancer. 27-35 The NHSBSP provides screening by invitation every three years for women between the ages of 50 and 70 years (by 2004); women over the age of 70 years are encouraged to participate. Two-view mammography (mediolateral oblique and craniocaudal projections of each breast) is required at each attendance (by 2003).
Trials are
underway to assess the optimal screening interval and ages at which population
screening is cost-effective. Until the results of these trials are available,
screening of women of 50 years and older as currently provided by the NHSBSP is
all that can be recommended.
2.2.3 Screening
women between the ages of 40 and 49 years
Screening in this age group remains controversial. Although there is now some evidence to suggest mortality benefit, this occurs later and is less than the reduction in women over 50 years of age. Consequently there is some doubt regarding the risks and cost-effectiveness of population screening in this age group. 36-44 The results of a prospective randomised trial of women age 40-47 years are awaited in the UK, and routine population screening of women aged 40-49 years is not currently recommended.
Individual women in this age group who seek or are referred for mammographic screening should be made fully aware of the risks (the theoretical radiation risks and the increased rates of false reassurance, false-positive and false-negative results and benign surgical biopsies compared to screening in older women) as well as the possible benefits, before being screened. Two-view mammography at each screening visit is recommended and mammography is unlikely to be of benefit in this age group if performed less frequently than annually; 45-47 screening more frequently than every year is not recommended.
2.2.4 Screening
women under the age of 40 years
There is no evidence of any mortality benefit from mammographic screening of women under the age of 35 years. 48-50 There are also greater theoretical risks of radiation-induced breast cancer from the use of diagnostic x-ray mammography in young women. 51 For these reasons, routine screening of women in this age group in the absence of any significant breast cancer risk factors is not recommended.
2.2.5 Assessment
of screen-detected
abnormalities
In the NHSBSP it is routine for all screen-detected abnormalities (symptomatic and asymptomatic) to be assessed by a multidisciplinary team of breast specialists, and it is policy that the NHSBSP has the responsibility to carry out all tests required to confirm definitively the presence or absence of malignancy.24
2.2.6 Screening
in the private sector
A significant
amount of mammographic screening occurs outside the NHS. Radiologists involved
in non-NHS screening
should satisfy the same professional standards as apply to the NHSBSP and
should ensure that further assessment procedures, to the same standard as apply
in the NHSBSP, are in place for all non-NHS screen detected abnormalities. Further assessment
procedures should be discussed and agreed with the patient before screening is
carried out.
3 Breast Imaging Protocols
3.1 Symptomatic breast imaging
Conventional
routine techniques for imaging the breast are x-ray mammography and ultrasound. Mammography is the
most sensitive routine imaging technique for demonstrating malignant disease in
the breast. However, it does involve ionising radiation and should be used only
where there is a reasonable risk of malignancy. Breast cancer is uncommon under
the age of 35 years and is rare under the age of 30 years. Mammography is also
less sensitive for breast disease in younger women because, in general, the
normal breast is denser and more difficult to interpret. For these reasons, the
recommended protocols for the use of breast imaging are age-dependent.
3.1.1 Imaging of
symptomatic patients over 35 years:
- mammography is the imaging technique of first choice. It is recommended that the standard mammographic examination should normally include a mediolateral oblique and a craniocaudal projection of each breast. Supplementary projections may be performed as directed by the supervising radiologist;
- breast ultrasound may provide useful additional information and may be used to complement mammography, as decided by the supervising radiologist. Ultrasound may be used as the initial imaging technique where clinical examination suggests the presence of a benign process such as a simple cyst; 52
- mammography may be performed as a matter of routine and in the absence of significant clinical signs in women of 50 years or over who have not previously or recently attended for screening as part of the NHSBSP. Ultrasound is not regarded as a suitable technique for routine breast cancer screening. 26
3.1.2 Imaging of
symptomatic patients under 35 years:
- a sizeable proportion of women attending breast clinics are under 35 years of age 53,54 and many do not require imaging as part of their diagnostic assessment.55 There is a low incidence of breast cancer in this age group53,56 and diagnosis is normally achieved by clinical assessment, supplemented where necessary by fine needle aspiration/core needle biopsy and imaging; 13,17, 57-59
- ultrasound is the imaging technique of first choice in women under 35 years with focal breast problems;55
- however, where malignancy is suspected, mammography with two views (mediolateral oblique and cranio-caudal projections) of each breast should be performed.
3.2 Mammographic screening of patients at increased risk of breast cancer
At best there
is limited evidence that screening women at increased risk of breast cancer
confers benefit.
3.2.1 Family
history
Only a small proportion of breast cancer is hereditary and linked to highly penetrant dominant genes. 60 Evidence that mammographic screening offers any benefit to women with a significant family history of breast cancer is still limited because of the small size of most studies compared with the large randomised control trials. 61-68 The results, in terms of number and stage of cancer detected, in women deemed at high risk because of their family history and screened at 40-50 years of age are comparable to population screening of women aged over 50 years. Breast magnetic resonance imaging (MRI) has shown potential as a sensitive screening test 64 but is extremely expensive. A trial is underway in the UK evaluating the use of MRI as a screening test in high-risk women. 69 The recommendations are therefore based on currently suggested best practice:
- any mammographic screening of women in this risk group should be planned and follow agreed protocols (Appendix A) and be subject to prospective data collection;
- women who participate should do so only with fully informed consent, 25 to include information about possible benefits and possible risks (rates of false-positive and false-negative results and their implication for false reassurance and interventions for what prove to be benign disease, and the potential radiation risks associated with frequent mammography undertaken from a young age);
- risk assessment and counselling are fundamental prerequisites to mammographic screening in these circumstances; up to half of those referred for family history screening are not at significantly increased risk of developing breast cancer;
- it is recommended that family history screening should be carried out under the direct supervision of a clinician who has a special interest in family history breast cancer screening;
- mammography may be part of routine family history screening and should be performed following protocols agreed between the clinician in charge of the family history service and the specialist radiologist. These protocols should clearly define eligibility criteria and the methods and frequency of screening examinations and a formal mechanism for ensuring that any abnormalities detected are further assessed without delay by a specialist multidisciplinary breast team;
- family history risk decreases with age and, for the majority of women with a significant family history of age 50 years or over, screening - as provided by the NHSBSP - is likely to be sufficient;
- the use of mammography in screening at risk women under 35 years of age should not be routine;
- radiologists should ensure that mammography performed as part of family history screening is of optimal quality and that unnecessary exposure to radiation is avoided.
The optimum frequency for performing mammography as part of screening women at increased risk of breast cancer is uncertain and depends on age. It is suggested that screening mammography should be more frequent in younger women.70 It is recommended that screening mammography should be performed every one to two years. More frequent mammography is not recommended.
3.2.2 Previous
benign breast biopsy
In most cases (70%) a history of previous benign breast biopsy carries no increased risk of subsequent development of breast cancer. 71-73 However, a past history of biopsy showing proliferative epithelial changes is associated with an increased risk of breast cancer (four times the relative risk). 74-77 This risk is doubled if there is also a family history of breast cancer in a first-degree relative. 78 There is no evidence that screening of women with proliferative changes offers any mortality benefit. However, it is accepted practice to offer screening to women in this risk category; local clinical practice will determine whether or not screening is offered in these circumstances. Screening should follow the same guidance as recommended for family history screening.
3.2.3 Mammography
in women receiving HRT
A collaborative
re-analysis of 51 epidemiological
studies has demonstrated a higher risk of having breast cancer in women using
HRT and this is dependent on the duration of use.
The relative risk is 1.35 for women using HRT for five years or longer and the effect is largely resolved five years after discontinuing HRT. 79 These results have been corroborated in a recent large randomised control trial which reported a relative risk of 1.26 over controls for women using HRT.80 Less is known regarding the effects of individual HRT preparations. HRT has been shown to increase breast density and benign changes within the breast. There is a subsequent fall in sensitivity and specificity and an increased recall rate from screening.81-86
3.2.3.1 "Baseline"
mammography is not routinely required prior to commencing HRT.
3.2.3.2 The majority of women receiving HRT are over the age of 50 years and are offered screening every three years as part of the NHSBSP as a matter of routine. In this age group, there is no evidence to support more frequent screening. However, a decreased sensitivity and specificity for breast cancer have been reported - although two-view mammography may offset the decreased sensitivity.
3.2.3.3 For women under the age of 50 years the effectiveness of screening may be reduced by the factors laid out above 81-86 and the conclusions are the same as stated in 1.2.3 in that routine screening is not recommended.
3.3 The use of imaging in the follow-up of patients with breast cancer
Patients who have been treated for breast cancer may develop recurrence of the primary cancer or distant metastatic disease and are at increased risk of developing a second primary breast cancer (six times the lifetime risk). 87-89 The aim is to detect recurrence or a second primary as early as possible to maximise the likelihood that treatment will influence prognosis. 90
3.3.1 Imaging of
the treated breast following surgery with breast conservation
Recurrence is likely to show the same mammographic features as the primary lesion, 91 so although interpretation may be hampered by post-operative scaring and radiation changes 92 in a combined clinical and imaging follow-up regime, mammography can be expected to detect 30-40% of clinically occult recurrence 93 and these are likely to have better prognostic features. 94-96
3.3.2 Imaging of
the opposite breast after treatment for breast cancer
Monitoring the contralateral breast will detect a higher proportion of better prognostic cancers than clinical examination. 97,98
3.3.3 Frequency
and duration of follow-up
3.3.3.1 Clear evidence on the frequency of follow-up mammography is not available, 99 but it is considered reasonable practice that it should be at least once every two years and no more frequently than annually. This concurs with the Clinical Outcomes Group guidelines, which advocate annual mammography for five years and two-yearly thereafter. 8 The duration of follow-up is similarly unclear but should take into account that the majority of recurrence will occur within 10 years of diagnosis and that 80% of contralateral breast cancers will have arisen within 10 years of the primary diagnosis.
3.3.3.2 Routine imaging investigation of women without clinical evidence of metastatic disease has a very low yield 100 and does not significantly reduce time to detection of metastatic disease, improve survival or influence quality of life. 101-104 Investigation should be restricted to those where the presence of metastasis will alter patient management.
3.3.3.3 Traditionally, imaging post-treatment has been performed concurrently with clinical surveillance under the supervision of a surgeon and/or oncologist 105 but more recent work has suggested alternative models of delivering follow-up care 106-108 using mammography alone with rapid access to triple assessment or using nurse-led clinics. This model of limited clinical follow-up (two to three years) with easy access to a specialist clinic and mammographic surveillance is advocated by the latest Clinical Outcomes Group guidance. 109 Long-term data is not available, so these alternative methods should be subject to rigorous audit.
3.3.3.4 Once an abnormality is detected, either clinically or radiologically, rapid access is required to special view mammography and ultrasound. Confirmation requires needle biopsy for histology or cytology.
3.3.3.5 Where conventional triple assessment has been unhelpful in the investigation of patients with suspected recurrences, MRI has been shown to be useful. 110
3.4 Imaging of women with breast implants 111
3.4.1 Introduction
Only a small number of women in the UK have had breast augmentation (0.2% of women attending for breast screening). However, mammography carried out on these women often presents significant technical and interpretational difficulties. The presence of implants is very likely to lower both the sensitivity and specificity of diagnostic or screening mammography. The advice provided in these guidelines is designed to optimise the diagnostic value of imaging women with breast prostheses and is based on the considerable experience of imaging the augmented breast in the USA, where around two million women have undergone this procedure.
3.4.2 General
points
3.4.2.1 Women with a
prosthesis who undergo mammography - and the radiographers who perform
their examinations - should be aware that the risk of prosthesis rupture
as a result of compression during mammography is extremely small.
3.4.2.2 The presence of any visible breast asymmetry should, however, be recorded before mammography is performed in case the examination is blamed for producing an existing abnormality.
3.4.2.3 There is no evidence that breast augmentation is associated with an increased incidence of carcinoma.
3.4.3 Examination
of women with symptoms
3.4.3.1 Women should have
had a clinical examination by an experienced clinician prior to imaging.
3.4.3.2 Ultrasound of the area of suspicion is the preferred initial imaging method, and is particularly valuable for mass lesions. 112
3.4.3.3 Should mammography be considered necessary, the displacement techniques described by Eklund 113 are particularly valuable for calcifications and for parenchymal deformities in women with a small prosthesis occupying less than 50% of breast volume.
3.4.3.4 In consultation with the clinician, ultrasound-guided fine needle aspiration cytology (FNAC) can often prove extremely valuable.
3.4.3.5 MRI may provide further useful information regarding the presence of malignancy and implant rupture. 114
3.4.4 Breast
screening
3.4.4.1 In the NHSBSP,
prostheses are present in fewer than 2 per 1,000 women screened and, therefore,
do not present a significant problem. Screening by mammography is still
considered the most appropriate modality for excluding breast cancer.
3.4.4.2 If practicable, women should be given appointments to attend a unit where films can be processed and additional mammographic views can be performed. A longer than usual appointment time will be required.
3.4.4.3 The screening examination must be "tailored" to each woman. The most appropriate mammographic technique is dependent on the volume and position of the implants in the breasts. The following procedure is suggested:
- mediolateral oblique views should be performed initially to assess the size and position of the prostheses;
- cranio-caudal views using Eklund displacement technique;
- for small prostheses (less than 50% of breast volume) a three view technique (mediolateral oblique, true lateral and cranio-caudal projections) will show at least 70% of breast volume if the displacement technique is used;
- for moderate sized prostheses (50-75% of breast volume) each case should be judged on its own merits;
- for large prostheses (more than 75% of breast volume) further x-ray mammography is not usually indicated;
- ultrasound is not recommended for screening 26 but, if used for women with breast prostheses because mammograms of diagnostic quality are not obtainable, women must be made aware of the high false-negative results associated with this technique. All efforts must be made to avoid false reassurance.
3.4.4.4 Each woman should be
provided with advice about the value of mammographic screening according to the
size of her particular prostheses. "Breast awareness" is an
important back-up
technique for this group of women.
3.4.5 Implant
integrity
Despite widespread interest in this issue, the prevalence of implant rupture and the frequency and severity of sequelae of implant rupture are not known. Most of the published studies on this subject are typically case series and so comparison is difficult. There does, however, seem to be evidence to suggest that the longer implants have been present the greater the likelihood of leakage or rupture. The rates of implant disruption seem to be similar in women with and without symptoms.115
Mammography,
ultrasonography and MRI have all been used, with varying success, to detect
implant rupture.
3.4.5.1 Mammography
Implants with intra-capsular rupture and collapse of the implant shell may maintain their normal shape because of the fibrous capsule and be elusive to mammographic detection. Posterior extra-capsular leakage of silicone may also be difficult to detect. Sensitivity in detecting implant rupture by mammography has been reported as ranging from 5-69% with specificity of 82-100%. 115,116
3.4.5.2 Ultrasonography
Correct interpretation requires considerable experience and false-positive cases may present problems. Sensitivity reported varies from 47-70% and specificity from 57-92%. 115 Venta et al. found that a normal ultrasound examination was highly predictive (91%) for an intact implant. 117 Ultrasound might therefore be used as an initial investigation and patients with an abnormal examination should proceed to an MRI examination.
3.4.5.3 MRI
There seems little doubt that MRI is now the investigation of choice for the diagnosis of - or exclusion of - implant rupture. Virtually all published series have, however, been performed on a 1.5 T magnet and translation of data down to 1.0 T or 0.5 T magnets should be carried out with caution. Sensitivities between 46% and 98% with specificity of 95-98% have been reported in those studies that used a dedicated breast coil. The ability of MRI to detect both intra- and extra-capsular rupture and the detection of migration of free silicone away from the implant site are reasons for its superior performance. 118-119
MRI is the modality of choice for implant rupture however its availability remains variable throughout the UK. 114
3.5 Image-guided breast interventional procedures
3.5.1 Percutaneous sampling of breast lesions is important to avoid unnecessary surgery for benign problems and provide pre-operative diagnosis of malignant lesions, allowing for informed patient counselling and treatment planning. 7, 120,121 The radiologist plays an important role in obtaining representative tissue, particularly from impalpable lesions. Needle aspiration and/or biopsy should be performed on all clinically or radiologically indeterminate, suspicious or malignant breast abnormalities. Radiologists involved in image-guided sampling of breast lesions are advised to work to written protocols.
3.5.2 FNAC and
wide-bore core biopsy (WBCB)
3.5.2.1 FNAC and WBCB are
essential components of triple assessment and radiologists with a special
interest in breast imaging should be skilled in these techniques.
3.5.2.2 To ensure accurate sampling, image guidance may be the preferred technique for sampling palpable as well as impalpable lesions.
3.5.2.3 Ultrasound guidance is recommended where lesions can be confidently seen on ultrasound.
3.5.2.4 Stereotaxis is the recommended technique for guiding biopsy of lesions not clearly visible on ultrasound. For x-ray-guided biopsy, check films must be performed to confirm that the appropriate area is sampled.
3.5.2.5 FNAC and WBCB should be performed after full clinical assessment.
3.5.2.6 The recommended techniques for FNAC are fully described in the Guidelines for Non-Operative Diagnostic Procedures and Reporting in Breast Cancer Screening. 122
3.5.2.7 For individual radiologists performing image-guided FNAC, an absolute adequacy rate of more than 70% is required.
3.5.2.8 For WBCB, the best results are likely to be achieved if 14-gauge needles are used with a spring-loaded biopsy device.
3.5.2.9 WBCB is suggested for microcalcifications, and specimen radiography is required to confirm adequate sampling. 24
3.5.2.10 Vacuum-assisted biopsy will yield greater amounts of tissue which should produce greater diagnostic accuracy. 123 However, the equipment is expensive and its exact role is still being established.
3.5.3 Localisation
of impalpable lesions for surgical biopsy and excision
3.5.3.1 Localisation should
allow accurate excision of the abnormality in order to obtain a diagnostic
sample weighing less than 20 grams.
3.5.3.2 The technique or techniques used are determined by the type and position of the lesion being targeted and by the preferences of radiologists and surgeons.
3.5.3.3 Ultrasound guidance is recommended where lesions can be confidently seen on ultrasound. Skin marking may be preferred for superficial lesions.
3.5.3.4 Wire localisation is recommended for more deep-seated abnormalities; the wire should pass within 10 mm of the margin of the lesion. It is recommended that check films should always be performed to confirm accurate localisation; if not the procedure should be repeated.
3.5.3.5 Following excision, specimen radiography should be performed for all image-guided localisations for impalpable lesions to confirm that adequate excision or sampling has been achieved. Section radiography will aid histopathological assessment of these specimens. A dedicated specimen x-ray machine is preferred.
3.6 Supplementary imaging techniques
3.6.1 MRI 114, 124-126
The exact role
of breast MRI in the investigation and management of breast cancer has yet to
be fully established. Breast MRI has advantages in high sensitivity for
invasive (but less so for in situ) disease and does not use ionising radiation. It may
be useful in evaluating potential recurrence following conservation surgery,
the detection of multifocal disease and the evaluation of patients undergoing
neoadjuvant chemotherapy. Patients with breast implants can be assessed for
implant integrity and the presence of suspected malignancy. The disadvantages
of MRI are its expense, limited availability, a wide variation in reported
specificity and the lack of biopsy facilities for lesions detected by MRI
alone. Further trials are required before the exact role of breast MRI in
breast cancer management can be established.
3.6.2 Scintimammography 127-130
Breast cancer
and nodal metastases can be detected using 99mTc Sestamibi and other isotopes.
Some have advocated scintimammography for problem solving, in dense breasts,
recurrent breast cancer following surgery, for sentinel node biopsy and in
monitoring tumour response to chemotherapy. Insufficient data is, however, available
at the present time for firm guidelines to be issued regarding the role of
nuclear medicine in breast cancer imaging, and particularly how it interrelates
with other imaging modalities.
4 Professional Standards
4.1 Radiologists involved in symptomatic breast imaging
Radiologists
with a special interest in symptomatic breast imaging should:
- assume responsibility for the provision and quality of imaging in symptomatic breast services;
- have undergone appropriate training in accordance with RCR guidelines;
- be personally involved in the interpretation and reporting of a minimum of 500 symptomatic mammograms per annum;
- be part of a multidisciplinary team associated with a designated specialist breast unit;
- have appropriate contracted time (identified in a personal job plan) specifically designated for participation in multidisciplinary breast assessment. It is anticipated that a specialist breast radiologist will require two, and preferably three, fixed sessions dedicated to breast assessment. This should include participation in diagnostic breast clinics organised to ensure that direct and timely consultation with the other members of the clinical team can take place;
- participate in regular (usually at least weekly) multidisciplinary clinical case management meetings;
- ideally also participate in the NHSBSP;
- possess the skills required to report mammography, perform and interpret breast ultrasound, supervise specialist mammography techniques and perform image-guided biopsy and localisation of impalpable breast lesions. Mammography and breast ultrasound reporting should use recognised and recommended descriptive terminology and include details of site, imaging size and nature of any abnormality with an opinion as to the likely diagnoses and recommendations for any further diagnostic procedure or intervention;
- participate in personal breast imaging audit and multidisciplinary breast service audit;
- participate in CME as recommended by the RCR and ensure that this includes an appropriate breast imaging content.
4.2 Radiologists involved in the NHSBSP
Professional
standards for radiologists involved in the NHSBSP have been previously
established (Quality Assurance Guidelines for Radiologists in Breast Cancer Screening). 7 The screening and symptomatic breast imaging professional guidelines are compared and summarised in Appendix B.
5 Equipment
This section provides guidance on equipment used for imaging as part of
the routine symptomatic breast assessment (x-ray mammography and breast ultrasound).
5.1 Imaging equipment sufficient for satisfactory diagnostic images
Radiologists involved in breast imaging should ensure that imaging equipment is of a sufficient standard to achieve satisfactory diagnostic images. Breast imaging in symptomatic practice should satisfy the technical and quality requirements laid down by the NHSBSP. 131,132
5.2 Mammography equipment for symptomatic breast imaging and breast screening assessment
For symptomatic
breast imaging and breast screening assessment, mammography equipment should be
capable of:
- obtaining all conventional mammographic projections;
- obtaining specialist projections including localised compression, magnification projections and stereotactic localisation (digital equipment for stereotaxis has significant advantages); 133,134
- be subject to routine regular quality control assessment to the standards required by the NHSBSP. 135
5.3 Ultrasound equipment for breast imaging
Ultrasound
equipment used for breast imaging should:
- operate at a minimum of 7.5 MHz and preferably be capable of achieving 10-13 MHz operating frequency;
- provide either hard copy images of appropriate diagnostic quality or the facility to archive and retrieve digital data;
- comply with the requirements laid down by IPEM 71; 136
- be subject to routine regular quality control assessment to the standards required by the NHSBSP. 137
6 Radiation Risks in Mammography 51
6.1 A review undertaken on behalf of the NHSBSP 138 has considered the radiation risk associated with breast screening. The rates of breast cancer induction have been recalculated and remain broadly similar to those previously published by the National Radiation Protection Board (NRPB). 139 It is recognised that there are large uncertainties in low-dose cancer risk estimates and, in its 2000 report, 140 the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) stated that the uncertainty in risks for solid cancers overall, following acute high exposures, may be a factor of around two, higher or lower, and that a further factor of two, higher or lower, may apply when estimating risks from chronic or low doses.
6.2 The NHSBSP review reached the
following conclusions:
- the risk of a radiation-induced cancer for a woman attending mammographic screening (two views) by the NHSBSP is about 1 in 20,000 per visit;
- 154 cancers are detected by the NHSBSP for every cancer induced;
- the natural incidence of breast cancer in the UK population may be increased by 0.2% due to radiation-induced cancers;
- screening with the NHSBSP regime of two views every three years from age 50 to 70 years is justified in radiation protection terms with 80 lives saved for every life lost due to radiation-induced cancers. This ratio depends upon the mortality reduction achieved by the screening programme and it falls to 53:1 if the reduction is 25% for screened women and rises to 106:1 if the mortality reduction is 40%;
- for the very small proportion of women who receive the highest radiation doses, the benefit will exceed the risk by about 16:1.
6.3 Law and Faulkner 51 have recently published estimated rates of cancers detected and induced in breast screening programmes. They have presented their data by age and family history of breast cancer and have inferred associated risks and benefits of various screening programmes. Their data are based upon estimates of cancer detection rates, radiation dose, and consequent cancer induction rates.
6.3.1 The
estimates of cancer detection rates are very robust for women aged 50-64
years (NHSBSP data) but based upon much smaller populations for younger women
with or without a family history of breast cancer.
6.3.2 The radiation doses received during screening mammography are presented as the mean glandular dose (MGD) and are derived from data published by Young and Burch. 141
6.3.3 Tables 1, 2 and 3 show data for three different doses: 3.65 mGy is the mean dose for a woman undergoing two-view mammography of each breast; 11 mGy and 20 mGy represent the doses exceeded by the top 2% and 0.1% of the population who receive higher doses of radiation primarily because of their greater breast size. Radiation-induced cancer rates have been calculated from work undertaken by the NRPB. 139
6.3.4 It is
acknowledged that estimates of cancer induction rates are more uncertain. In
view of such uncertainties, Young and Burch have suggested that the ratio of
detection to induction should exceed a factor of five for women over 40 years,
and a factor of 10 for younger women, and their conclusions derived from Tables
1, 2 and 3 are based upon this.
6.3.5 Young and
Burch also state that while the true benefit:risk ratio is not the same as the
ratio of cancers detected to those induced, it should be at least half this
ratio.
6.3.6 Law and
Faulkner conclude that, in the NHSBSP population, the benefit is likely to
exceed radiological risk by a substantial margin even for the top 0.1% of the
screened population that receive the highest radiation dose.
Table 1. Ratio of cancers detected to cancers induced in the NHSBSP, ages 50-64 years, with 3-yearly two-view screening at various doses
|
Cancers detected/induced
|
| Age (years) |
3.65 mGy
(mean MGD) |
11 mGy
(MGD level exceeded by
2% of women screened) |
20 mGy
(MGD level exceeded by
0.1% ofwomen screened) |
| 50-64 |
104 |
34 |
19 |
| 55-59 |
119 |
39 |
22 |
| 60-64 |
182 |
60 |
33 |
6.4 For younger women, without a
family history, the margin of benefit over risk is sufficient at the dose level
exceeded by 2% of the screened population down to the age of 40 years (see
Table 2).
Table 2. Cancers detected/cancers induced in younger women, ages
30-49 years, without family history, with annual two-view screening
|
Cancers detected/induced
|
| Age (years) |
3.65 mGy
(mean MGD) |
11 mGy
(MGD level exceeded by
2% of women screened) |
20 mGy
(MGD level exceeded by
0.1% ofwomen screened) |
| 30-34 |
2.6 |
0.85 |
0.47 |
| 35-39 |
6.1 |
2.0 |
1.1 |
| 40-44 |
11.0 |
3.8 |
2.1 |
| 45-49 |
20.0 |
6.7 |
3.7 |
6.5 For younger women with a
family history of breast cancer in a first-degree relative, and diagnosed at age 30-39
years, the margin of benefit over risk appears quite sufficient down to age 40
years at all three dose levels and down to 35 years to the dose level exceeded
by 2% of the screened group. Where the age of the relative at diagnosis is in
the 40-49-year
age band, the margin of benefit is somewhat reduced at all ages of screening
(see Table 3).
Table 3. Cancers detected/cancers induced in younger women, aged
25-49 years with family history, with annual two-view screening
|
Cancers detected/induced
|
| Age (years) |
Index
patient age
at diagnosis* |
3.65 mGy
(mean MGD) |
11 mGy
(MGD level exceeded by
2% of women screened) |
20 mGy
(MGD level exceeded by
0.1% ofwomen screened) |
| 25-29 |
30-39 |
6.0 |
2.0 |
1.1 |
| 30-34 |
|
20.0 |
6.7 |
3.7 |
| 35-39 |
|
42.0 |
14.0 |
7.6 |
| 40-44 |
|
54.0 |
18.0 |
10.0 |
| 45-49 |
|
60.0 |
20.0 |
11.0 |
|
|
|
|
|
| 30-34 |
40-49 |
12.0 |
4.0 |
2.2 |
| 35-39 |
|
20.0 |
6.8 |
3.7 |
| 40-44 |
|
33.0 |
11.0 |
6.0 |
| 45-49 |
|
36.0 |
12.0 |
6.7 |
*Index patient age at diagnosis (years) refers to the age at which the
first-degree relatives
(mother/daughter/sister) developed their breast cancer.
Tables 1, 2 and 3 are reproduced with kind permission of the British
Journal of Radiology.
6.6 Young and Burch 141 emphasise that the conclusions drawn are based on the assumption that the risk of radiation-induced breast cancer in women with a family history remains similar to that of the general population.
BFCR(03)2
Approved by the Board of the Faculty of Clinical Radiology: 1 November
2002
Approved by Council: 22 November 2002
Appendix A - Genetic Breast Cancer:
Criteria to Establish Those at Moderate Risk
Women considered to be at moderate risk of developing breast cancer as a result of their family history 65
- One first-degree relative - breast cancer < 40 years
- One first-degree female - bilateral breast cancer, first cancer diagnosed < 50 years
- Two first-degree or one first- and one second-degree female - both with breast cancer < 60 years (on the same side of the family)
- Two first-degree or one first- and one second-degree female - breast cancer < 60 years and ovarian cancer at any age (on the same side of the family)
- One first- or second-degree female - breast and ovarian cancer, first cancer diagnosed at < 60 years
- Three first- or second-degree female - breast or ovarian cancer at any age
- One first-degree male-breast cancer at any age
- Paternal history of a minimum of two second-degree relatives (father's first-degree relatives) with breast cancer < 50 years or breast cancer < 50 years and an ovarian cancer (any age), or paternal uncle/grandfather with breast cancer < 50 years
Satisfying one of these inclusion criteria gives an individual a risk
of developing breast cancer below the age of 50 years of 3% or above
Note: There is still some lack of consensus, so local guidelines may
differ, but remember that an increased genetic risk only occurs if a breast
cancer gene is present. Even with a strong family history, absence of a breast
cancer gene means that risks are not increased.
Women at increased risk should be counselled appropriately and, prior to consideration of screening by mammography, risks and benefits must be discussed. 25
Appendix B - Breast Radiologist Professional Standards
Professional standards for radiologists involved in breast imaging
(Royal College of Radiologists Breast Group)7
|
Screening
In order to gain and maintain expertise, each radiologist involved in screening should fulfil the following criteria.
a) Be employed for a minimum of 3 or preferably 4 or more notional half-days in breast imaging.
b) Undertake a minimum of 5,000 screening and/or symptomatic cases a year.
In addition, each radiologist should fulfil the following criteria.
a) Have attended an RCR approved course.
b) Be involved with assessment as well as basic screening.
c) Be experienced in the use and interpretation of sophisticated x-ray and ultrasound procedures.
d) Have access to pathology follow-up data.
e Have access to surgical follow-up data.
f) Undertake formal audit of performance.
It would be advantageous also to meet the following criteria.
a) Be involved with symptomatic breast work.
b) Have skills in clinical examination.
c) Participate in an approved radiologists' performance quality assurance scheme for mammography.
|
Symptomatic imaging
In order to gain and maintain expertise each radiologist involved in symptomatic work should fulfil the following criteria.
a) Be employed for a minimum of 1 or preferably more notional half-days in breast imaging with time specifically allocated for multidisciplinary breast assessment.
b) Undertake a minimum of 500 symptomatic cases per year.
In addition, each radiologist should fulfil the following criteria.
a) Have attended an RCR approved course.
b) Be involved with assessment as well as basic mammographic interpretation.
c) Be experienced in the use and interpretation of sophisticated x-ray and ultrasound procedures.
d) Have access to pathology follow-up data.
e) Have access to surgical follow-up data.
f) Undertake formal audit of performance.
It would be advantageous also to meet the following criteria.
a) Be involved with breast screening.
b) Have skills in clinical examination.
c) Participate in an approved radiologists' performance quality assurance scheme for mammography.
|
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