Research project
CESAR study
Contrast Enhanced mammography versus magnetic reSonance imaging for Assessing Response to neoadjuvant chemotherapy
Active
September 2024
August 2027
Funding
Funders
Funder: National Institute for Health and Care Research (NIHR)
Sponsor: University of Dundee
February 2026 - Update on CESAR
"Progress on the CESAR study continues to be exceptionally positive, and I am delighted to share that we are exceeding our recruitment targets. We have now welcomed over 81 participants into the study across our ten UK hospital sites - a milestone that reflects both the incredible dedication of our clinical teams and the vital contribution of our participants. We are well-positioned for continued growth and remain firmly on track to achieve our research goals." - Chief Investigator, Dr Sarah Savaridas
Information about our study
Breast cancer is the most common cancer in women in Europe. Women often have surgery to remove the cancer. Sometimes chemotherapy is given before surgery to shrink the cancer and make the surgery easier.
Scans and Mammograms
Scans are done before and after the chemotherapy to see whether it has worked. There are several different types of scans which can be used for this:
Mammograms
- Use low dose x-rays
- Are easy and quick to do
- Are quite cheap to do
MRI (Magnetic Resonance Imaging) Scans
- MRI scans give very clear pictures (images).
- MRI scans can be difficult for a patient to tolerate – they are noisy, and some patients do not like going into the narrow scan tunnel.
- MRI scans are not suitable for everyone - for example, you can’t have an MRI scan if you have metal in your body e.g. a pacemaker.
- MRI scans are expensive to do.
Contrast Enhanced Mammography (CEM)
- CEM is a new type of mammogram which we think could be used instead of MRI scans.
- CEM is very much like a normal mammogram, but a dye is used to make the image clearer.
- CEM is much quicker and easier to do than an MRI scan.
- CEM is cheaper to do than an MRI scan.
Why can’t we just use CEM? Why do we need to do a study?
A lot of hospitals use mammograms or MRI scans for these patients. Some hospitals are already using CEM. We need to test CEMs further to make sure they are as good as MRI scans.
Who will be invited to take part in the study?
Women over the age of 18 who are having chemotherapy followed by surgery to treat their breast cancer.
How will the study be done?
Women taking part in the study will have both types of scans before and after their chemotherapy. We will compare the results of both types of scans and ask the following important questions:
- Does CEM show up cancer as well as MRI?
- How well does CEM find other areas of cancer in the breast compared to MRI Scan?
- What do patients think of CEM?
- Do patients prefer CEM or MRI scan?
Have patients been involved in designing the study?
Yes, patients have been involved from the beginning and will continue to help us make sure that the study is done well and for the benefit of patients. This is called Patient and Public Involvement (PPI).
What will we do with the results?
The results of the study will be published by breast cancer charities so that all breast cancer patients can have access to them. They will also be published in medical journals and presented at conferences.
Aims of this research
Breast cancer is the most common female malignancy in the UK, affecting 1 in 8 women in their lifetime, with an incidence of 140.9/100,000 in the female population. (References 1,2)
Chemotherapy given prior to surgery - neoadjuvant chemotherapy (NACT) – is recommended in approximately 10% of women with primary breast cancer, to improve surgical options and allow assessment of chemosensitivity. In a recent joint James Lind Alliance and Association of Breast Surgeons (ABS) priority-setting exercise one of the key questions identified was ‘In patients having breast chemotherapy before surgery, what is the best way of monitoring the cancer and is it possible to tell whether the cancer has completely responded to treatment without performing an operation’. (Reference 3)
It is widely accepted that MRI is more accurate than ultrasound, mammography and clinical examination, (References 4-8) but this is not the universal standard-of-care. Emerging evidence suggests a relatively new imaging technique, Contrast Enhanced Mammography (CEM) may offer an alternative. (References 9-14) Like MRI, CEM uses contrast dye which makes it easier to see the cancer, and how big it is than on a normal mammogram.
The aims of this research study are to compare these two different types of imaging test for breast cancer and to provide evidence for:
- Whether CEM is good enough (non-inferior) to replace MRI scans for this purpose
- Which imaging test patients prefer through self-reported questionnaires
Patient eligibility criteria
- Patients aged over 18 years with invasive breast cancer
- Intention to treat with NACT
- Requirement for imaging monitoring with MRI
Site eligibility criteria
- UK-wide study
- MRI monitoring for NACT as standard of care, minimum pre- and post-NACT
- MRI protocol as per local practice
- CEM in clinical use or be CEM ready
- Site recruitment target:15-25 participants
Current study status: Research Ethics Committee approval ID - 24/LO/0834 (REC Name: London Bloomsbury)
IRAS ID: 333133
Contact us
For further details please contact:
- Dr Sarah Savaridas (Chief Investigator)
- Study contact email: [email protected]
References
1. Breast cancer: Key Points. 2021. https://www.scotpho.org.uk/health-wellbeing-and-disease/cancer-breast/key-points (accessed 30/04/2023 2023).
2. Cancer Registration Statistics, England 2020. 2022. https://digital.nhs.uk/data-and-information/publications/statistical/cancer-registration-statistics/england-2020/cancer-diagnoses-in-2020 (accessed 04/09/2023 2023).
3. Surgeons AoB. Breast Cancer Surgery Priority Setting Partnership. 2022. https://associationofbreastsurgery.org.uk/professionals/research/breast-cancer-surgery-priority-setting-partnership/ (accessed 28/06/2022 2022).
4. Lobbes MBI, Prevos R, Smidt M, et al. The role of magnetic resonance imaging in assessing residual disease and pathologic complete response in breast cancer patients receiving neoadjuvant chemotherapy: a systematic review. Insights into Imaging 2013; 4(2): 163-75.
5. Gu Y-L, Pan S-M, Ren J, Yang Z-X, Jiang G-Q. Role of Magnetic Resonance Imaging in Detection of Pathologic Complete Remission in Breast Cancer Patients Treated With Neoadjuvant Chemotherapy: A Meta-analysis. Clinical Breast Cancer 2017; 17(4): 245-55.
6. Murphy C, Mukaro V, Tobler R, et al. Evaluating the role of magnetic resonance imaging post-neoadjuvant therapy for breast cancer in the NEONAB trial. Internal Medicine Journal 2018; 48(6): 699-705.
7. Croshaw R, Shapiro-Wright H, Svensson E, Erb K, Julian T. Accuracy of Clinical Examination, Digital Mammogram, Ultrasound, and MRI in Determining Postneoadjuvant Pathologic Tumor Response in Operable Breast Cancer Patients. Annals of Surgical Oncology 2011; 18(11): 3160-3.
8. Fowler AM, Mankoff DA, Joe BN. Imaging Neoadjuvant Therapy Response in Breast Cancer. Radiology 2017; 285(2): 358-75.
9. Savaridas SL, Vinnicombe SJ, Warwick V, Evans A. Predicting the response to neoadjuvant chemotherapy. Can the addition of tomosynthesis improve the accuracy of contrast-enhanced spectral mammography? A comparison with breast MRI. Br J Radiol 2023; 96(1148): 20220921.
10. Hogan MP, Horvat JV, Ross DS, et al. Contrast-enhanced mammography in the assessment of residual disease after neoadjuvant treatment. Breast Cancer Res Treat 2023; 198(2): 349-59.
11. Bernardi D, Vatteroni G, Acquaviva A, et al. Contrast-Enhanced Mammography Versus MRI in the Evaluation of Neoadjuvant Therapy Response in Patients With Breast Cancer: A Prospective Study. AJR Am J Roentgenol 2022.
12. Barra FR, Sobrinho AB, Barra RR, et al. Contrast-Enhanced Mammography (CEM) for Detecting Residual Disease after Neoadjuvant Chemotherapy: A Comparison with Breast Magnetic Resonance Imaging (MRI). BioMed Research International 2018; 2018: 1-9.
13. Patel BK, Hilal T, Covington M, et al. Contrast-Enhanced Spectral Mammography is Comparable to MRI in the Assessment of Residual Breast Cancer Following Neoadjuvant Systemic Therapy. Ann Surg Oncol 2018; 25(5): 1350-6.
14. Iotti V, Ravaioli S, Vacondio R, et al. Contrast-enhanced spectral mammography in neoadjuvant chemotherapy monitoring: a comparison with breast magnetic resonance imaging. Breast Cancer Res 2017; 19(1): 106.
Related groups
Population Health and Genomics