Information to our patients
CONCERNS ABOUT SAFETY OF GADOLINIUM-BASED CONTRAST AGENTS (GBCAs)
A controversial debate about the safety of GBCAs recently prompted the European Medicines Agency and the U.S. Food and Drug Administration (see documents: FDA, EMA, ISMRM), to consider the clinical use of GBCAs in MRI. EUSOBI consider that indications for contrast-enhanced breast MRI as defined in our recommendations (Breast MRI: guidelines from the European Society of Breast Imaging and Breast MRI: EUSOBI Recommendations for women’s information) are still valid, and we believe that no breast MRI examination should be cancelled because the advantages (diagnosing breast cancer) clearly outweigh the possible problems contrast material could cause. We will modify our approach in the light of new evidence if appropriate.
We are happy to announce the book, ‘Screening & Beyond’, created especially for the International Day of Radiology.
It is packed with information provided by many of the world’s top experts on breast imaging, including member of EUSOBI – European Society of Breast Imaging, the Society of Breast Imaging, ESTRO, European Institute for Biomedical Imaging Research and EUROPA DONNA – The European Breast Cancer Coalition
EUSOBI has published several information papers for women:
Breast ultrasound: recommendations for information to women and referring physicians by the European Society of Breast Imaging
Andrew Evans, Rubina M. Trimboli, Alexandra Athanasiou, Corinne Balleyguier, Pascal A. Baltzer, Ulrich Bick, Julia Camps Herrero, Paola Clauser, Catherine Colin, Eleanor Cornford, Eva M. Fallenberg, Michael H. Fuchsjaeger, Fiona J. Gilbert, Thomas H. Helbich, Karen Kinkel, Sylvia H. Heywang-Köbrunner, Christiane K. Kuhl, Ritse M. Mann, Laura Martincich, Pietro Panizza, Federica Pediconi, Ruud M. Pijnappel, Katja Pinker, Sophia Zackrisson, Gabor Forrai, Francesco Sardanelli, for the European Society of Breast Imaging (EUSOBI), with language review by Europa Donna – The European Breast Cancer Coalition
Insights Imaging (2018). https://doi.org/10.1007/s13244-018-0636-z
This article summarises the information that should be provided to women and referring physicians about breast ultrasound (US). After explaining the physical principles, technical procedure and safety of US, information is given about its ability to make a correct diagnosis, depending on the setting in which it is applied. The following definite indications for breast US in female subjects are proposed: palpable lump; axillary adenopathy; first diagnostic approach for clinical abnormalities under 40 and in pregnant or lactating women; suspicious abnormalities at mammography or magnetic resonance imaging (MRI); suspicious nipple discharge; recent nipple inversion; skin retraction; breast inflammation; abnormalities in the area of the surgical scar after breast conserving surgery or mastectomy; abnormalities in the presence of breast implants; screening high-risk women, especially when MRI is not performed; loco-regional staging of a known breast cancer, when MRI is not performed; guidance for percutaneous interventions (needle biopsy, pre-surgical localisation, fluid collection drainage); monitoring patients with breast cancer receiving neo-adjuvant therapy, when MRI is not performed. Possible indications such as supplemental screening after mammography for women aged 40–74 with dense breasts are also listed. Moreover, inappropriate indications include screening for breast cancer as a stand-alone alternative to mammography. The structure and organisation of the breast US report and of classification systems such as the BI-RADS and consequent management recommendations are illustrated. Information about additional or new US technologies (colour-Doppler, elastography, and automated whole breast US) is also provided. Finally, five frequently asked questions are answered.
EUSOBI has published several information papers for women:
Mammography: an update of the EUSOBI recommendations on information for women.
Sardanelli F, Fallenberg EM, Clauser P, Trimboli RM, Camps-Herrero J, Helbich TH, Forrai G; European Society of Breast Imaging (EUSOBI), with language review by Europa Donna–The European Breast Cancer Coalition.
Insights Imaging. 2017 Feb;8(1):11-18. doi: 10.1007/s13244-016-0531-4. Epub 2016 Nov 16.
This article summarises the information to be offered to women about mammography. After a delineation of the aim of early diagnosis of breast cancer, the difference between screening mammography and diagnostic mammography is explained. The need to bring images and reports from the previous mammogram (and from other recent breast imaging examinations) is highlighted. Mammography technique and procedure are described with particular attention to discomfort and pain experienced by a small number of women who undergo the test. Information is given on the recall during a screening programme and on the request for further work-up after a diagnostic mammography. The logic of the mammography report and of classification systems such as R1-R5 and BI-RADS is illustrated, and brief but clear information is given about the diagnostic performance of the test, with particular reference to interval cancers, i.e., those cancers that are missed at screening mammography. Moreover, the breast cancer risk due to radiation exposure from mammography is compared to the reduction in mortality obtained with the test, and the concept of overdiagnosis is presented with a reliable estimation of its extent. Information about new mammographic technologies (tomosynthesis and contrast-enhanced spectral mammography) is also given. Finally, frequently asked questions are answered.
Translations available in:
Breast MRI: EUSOBI recommendations for women’s information.
Mann RM, Balleyguier C, Baltzer PA, Bick U, Colin C, Cornford E, Evans A, Fallenberg E, Forrai G, Fuchsjäger MH, Gilbert FJ, Helbich TH, Heywang-Köbrunner SH, Camps-Herrero J, Kuhl CK, Martincich L, Pediconi F, Panizza P, Pina LJ, Pijnappel RM, Pinker-Domenig K, Skaane P, Sardanelli F; European Society of Breast Imaging (EUSOBI), with language review by Europa Donna–The European Breast Cancer Coalition.
Eur Radiol. 2015 Dec;25(12):3669-78. doi: 10.1007/s00330-015-3807-z. Epub 2015 May 23. Review.
This paper summarizes information about breast MRI to be provided to women and referring physicians. After listing contraindications, procedure details are described, stressing the need for correct scheduling and not moving during the examination. The structured report including BI-RADS® categories and further actions after a breast MRI examination are discussed. Breast MRI is a very sensitive modality, significantly improving screening in high-risk women. It also has a role in clinical diagnosis, problem solving, and staging, impacting on patient management. However, it is not a perfect test, and occasionally breast cancers can be missed. Therefore, clinical and other imaging findings (from mammography/ultrasound) should also be considered. Conversely, MRI may detect lesions not visible on other imaging modalities turning out to be benign (false positives). These risks should be discussed with women before a breast MRI is requested/performed. Because breast MRI drawbacks depend upon the indication for the examination, basic information for the most important breast MRI indications is presented. Seventeen notes and five frequently asked questions formulated for use as direct communication to women are provided. The text was reviewed by Europa Donna-The European Breast Cancer Coalition to ensure that it can be easily understood by women undergoing MRI.
Translations available in:
Mammography: EUSOBI recommendations for women’s information.
Sardanelli F, Helbich TH; European Society of Breast Imaging (EUSOBI).
Insights Imaging. 2012 Feb;3(1):7-10. doi: 10.1007/s13244-011-0127-y. Epub 2011 Oct 28.
This paper summarises the basic information to be offered to women who undergo mammography. After a delineation of the general aim of early diagnosis of breast cancer, the main difference between screening mammography and diagnostic mammography is explained. The best time for scheduling mammography in fertile women is defined. The need to bring images and reports from the previous mammogram (and from other recent breast imaging examinations) is highlighted. The technique and procedure of mammography are briefly described with particular attention to discomfort and pain experienced by a fraction of women who undergo the test. Information is given on the recall during a screening program and on the request for further work-up after a diagnostic mammography. The logic of the diagnostic mammography report and of classification systems such as BI-RADS and R1-R5 is illustrated, and brief but clear information is given about the diagnostic performance of the test, with particular reference to interval cancers. Moreover, the breast cancer risk due to radiation exposure from mammography is compared to the reduction in mortality obtained with the test, and the concept of overdiagnosis is presented. Finally, five frequently asked questions are answered.
How painful is breast compression for mammography?
Mammography is tolerated well by the vast majority of women. In particular, it is painless for about 40–50 % of women, a little painful for 40 %, rather painful for 12 % and very painful only for 4 %. Pain disappears immediately after the procedure for 76 % of the women, while it lasts several minutes for 13 %, several hours for 7 % and more than 1 day for 4 % . However, the advantages of compression are clear, and unnecessary pain may sometimes be avoided by suitable scheduling (see Note A). The radiographer will guide you through all the steps of the examination and will take care of minimising the discomfort during breast compression.
Note A. To reduce pain or discomfort due to breast compression and to get the best mammograms, you should relax during the procedure; in particular, the pectoral muscles should be relaxed. Follow the radiographer’s instructions exactly and bear in mind that heavier compression means a lower x-ray dose, higher image quality and easier diagnosis. If you previously experienced a painful mammography in the premenstrual phase, try to arrange the next one from day 7 to day 12 of your cycle.
When should the first mammogram be done? What are the time intervals for further examinations?
Different recommendations are issued by different radiological and cancer societies as well by health authorities and governmental bodies. There is a general agreement on the usefulness of screening mammography from 50 to 70 years of age, with a time interval depending on several factors (for more details see ). Extension from about 40–45 to about 75 is now adopted by several screening programmes. When starting at 40, a 1-year interval can be recommended up to 45–50, considering the probable higher density and the possible faster growth of the tumour. After 50, the optimal interval may be decided based on personal history and breast density. If you have symptoms, mammography may be necessary for you at any age. If you are a woman with an increased risk for breast cancer (gene mutation carrier, multiple breast/ovarian cancer in the family), screening should start before age 40, according to your personal calculated risk level, access to special screening programmes, and other factors.
Note B. If you are invited to attend an organised screening programme, follow the programme’s planned interval. If you have any doubts about this time interval, or the usefulness of ultrasound as a supplemental screening method, consult your radiologist. If there are a high number of incidences of breast cancer in your family, especially at a young age and before menopause, you may need to have a screening with MRI [3, 4]: consult your radiologist and/or a specialised centre (e.g. a family cancer clinic). Information on indications to MRI are available in a EUSOBI dedicated paper .
What about screening mammography for women over 75?
The continuous increase in life expectancy prevents defining a clear cut upper age limit for screening mammography. A general suggestion is to continue screening with mammography for elderly women as long as their health is not significantly compromised by illness that drastically reduces life expectancy [5, 6]. Discuss this decision with your radiologist.
Can women with breast implants or breast reconstruction undergo mammography?
Yes, in the majority of cases they can. Special views with back placement of the implant are commonly needed, as well as specific technical expertise by the radiographer. Exceptions where mammography cannot be performed are breast reconstructions after complete gland tissue removal. Mammography limitations due to the presence of implants can be counteracted by an accurate clinical breast examination and breast ultrasound.
Note C. Always tell the radiologist and/or the radiographer if you have breast implants.
Is x-ray radiation from mammography dangerous?
The x-ray radiation associated with a mammogram is low. See in this article the section “Radiation exposure from mammography” for a comparison between the risk of radiation-induced breast cancer and the reduction of breast cancer mortality due to mammography.
What is the role of new technologies like tomosynthesis and CESM?
The role of these new technologies is to help in the detection and diagnosis of breast cancers. Tomosynthesis is commonly accepted as an effective tool for evaluation of symptomatic patients and suspicious findings at screening mammography. Large studies in the screening setting showed that tomosynthesis allows the identification of more cancers than mammography and potentially reduces the number of women recalled for benign findings. So far, CESM has been evaluated in a limited number of small studies. It provides useful information of suspicious lesions, increasing the visibility of malignant lesions, in particular in women with dense breasts, and can be an alternative to contrast-enhanced MRI, especially in the case of contraindications to MRI or to gadolinium-based contrast injection as well as of difficult MRI availability.
Is MRI screening harmful?
MRI does not use ionizing radiation, and consequently does not damage cells. There is no evidence that the magnetic fields and radiofrequency waves applied in MRI are harmful to humans. A little warming may occur, however this is by law restricted to a maximum of 1 degree core temperature. This potential effect is harmless. However, detection or exclusion of malignancy is only possible by intravenous injection of CM, which implies rare but severe side effects including life-threatening allergic reactions or nephrogenic systemic sclerosis (see ).
A controversial debate about the safety of GBCAs recently prompted the European Medicines Agency and the U.S. Food and Drug Administration (see documents: FDA, EMA, ISMRM), to consider the clinical use of GBCAs in MRI. EUSOBI consider that indications for contrast-enhanced breast MRI as defined in our recommendations ([4, 7]) are still valid, and we believe that no breast MRI examination should be cancelled because the advantages (diagnosing breast cancer) clearly outweigh the possible problems contrast material could cause. We will modify our approach in the light of new evidence if appropriate.
Should I bring my prior examinations and mammograms?
The availability of prior examinations improves the accuracy of the interpretation of breast MRI, resulting in increased sensitivity and decreased false positive rate. Therefore it is very important to take prior examinations (written reports and images, printed or on electronic device) with you to the appointment for breast MRI (unless these are already present in the center/hospital). This holds true for prior MRI examinations and for prior mammograms, ultrasonography, histopathology results of needle biopsy or surgical interventions, and any clinical records relevant to your case. All this information creates the basis for obtaining the most detailed diagnosis and proper recommendations from your current breast MRI examination.
When should MRI screening in high-risk women start? How often should MRI screening be repeated?
The onset of MRI screening is highly dependent on the indication for MRI screening. In women with a strong family history of breast/ovarian cancer, in particular those with BRCA1 or BRCA2 mutations, MRI screening should start at age 25 or 30. The proposed screening schedule is once yearly. This is more frequent than population-based mammographic screening due to the more rapid growth of breast cancers at young age. Please, note that one single case of breast cancer among your relatives, especially when happened after 50 years of age, does not mean that you are at high risk. If you have any concerns in this regard, consult your family doctor or your breast radiologist. They will decide whether they should refer or not to refer you to a specialized center for evaluating your risk.
Does preoperative MRI also detect additional cancers in women with very fatty breasts and in women over 60 or 70?
MRI detects additional cancers unseen by mammography and ultrasound in a fraction of women with breast cancer, even though in women with very fatty breasts the added MRI detection may be lower than in those with very dense breasts. Breast MRI similarly detects additional ipsilateral and contralateral breast cancers in women at any age, even though the potential impact of such additional cancer on disease-free and overall survival may decrease with age. There is no clear cutoff for breast density or age to be applied. Consequently, the choice for preoperative MRI should also be based on the considerations about the risk-benefit balance described above.
Is there any special indication for breast MRI when partial breast irradiation is under consideration?
If you are offered partial breast irradiation in the context of or outside a clinical trial, the possibility of having a breast MRI in order to verify that you really qualify for reduction of the field treated with radiation therapy (i.e. that no tumor foci remain outside the treated field), should be evaluated by your physicians in a multidisciplinary meeting. Note that the reported rate of patients who resulted not suitable for partial breast irradiation after a breast MRI is about 11%.
- Drossaert CHC, Boer H, Seydel ER (2002) Monitoring women’s experiences during three rounds of breast cancer screening: results from a longitudinal study. J Med Screen 9:168–175
- Sardanelli F, Fallenberg EM, Clauser P, et al (2017) Mammography: an update of the EUSOBI recommendations on information for women. Insights Imaging 8:11–18 . doi: 10.1007/s13244-016-0531-4
- Sardanelli F, Boetes C, Borisch B, et al (2010) Magnetic resonance imaging of the breast: recommendations from the EUSOMA working group. Eur J Cancer Oxf Engl 1990 46:1296–1316 . doi: 10.1016/j.ejca.2010.02.015
- Mann RM, Balleyguier C, Baltzer PA, et al (2015) Breast MRI: EUSOBI recommendations for women’s information. Eur Radiol 25:3669–3678 . doi: 10.1007/s00330-015-3807-z
- Simon MS, Wassertheil-Smoller S, Thomson CA, et al (2014) Mammography interval and breast cancer mortality in women over the age of 75. Breast Cancer Res Treat 148:187–195 . doi: 10.1007/s10549-014-3114-4
- Oeffinger KC, Fontham ETH, Etzioni R, et al (2015) Breast Cancer Screening for Women at Average Risk: 2015 Guideline Update From the American Cancer Society. JAMA 314:1599–1614 . doi: 10.1001/jama.2015.12783
- Mann RM, Kuhl CK, Kinkel K, Boetes C (2008) Breast MRI: guidelines from the European Society of Breast Imaging. Eur Radiol 18:1307–1318 . doi: 10.1007/s00330-008-0863-7