IMOGEN
Research type
Research Study
Full title
Contrast-Free Magnetic Resonance Imaging for Breast Disease
IRAS ID
287271
Contact name
Rajarshi Banerjee
Contact email
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
This is an observational cohort study looking at women, 30 years of age or older, with a concern or risk of suspected breast disease or breast cancer. This proposed study aims to examine the diagnostic performance of non-contrast MRI in breast disease by applying quantitative multiparametric MRI techniques.
Current standard of care for breast screening has high specificity and sensitivity for mammography of breast tissue that is not dense. Sensitivity drops significantly for breast tissue that is dense - this is significant for pre-menopausal women and post- menopausal women who commonly present with dense breast tissue. Indeed, determining the density of breast tissue is not a well-defined measure and research has shown variation across judgments made by radiologists in this regard. For post-menopausal women, the transformation of the breast tissue from dense to non-dense is a complex biological process.
Contrast MRI is, currently, a well regarding method for detecting breast cancer in women with dense breast tissue. However, this method and its use of gadolinium contrast agent is often not well performed, is poorly tolerated by patients and adds additional time to the scanning protocol. There is benefit to be had by utilising non-contrast MRI as part of the breast screening pathway. Quantitative measures of breast tissue could support better definition of the changes in breast tissue density, give measures of the fat content of breast tissue, as well as provide additional parameters within the search for methods for detecting cancer in dense breast tissue. This could all support a reduction in the number of women who need to have biopsies, as well as an improvement in the patient pathway.
The study includes up to 2 visits for MRI scans and blood tests over a 6 month period. All participants will receive standard-of-care by their healthcare provider/s.
REC name
West of Scotland REC 5
REC reference
20/WS/0110
Date of REC Opinion
4 Sep 2020
REC opinion
Further Information Favourable Opinion