This clinical trial tests the effect of adding magnetic resonance imaging (MRI) to usual care in detecting breast cancer in women with dense breasts and a 5-year breast cancer risk above 3% calculated by Prognosia Breast mammogram risk score (MRS) risk model. Mammography is the standard of care imaging used to screen for breast tumors. A mammogram uses film or a computer to create a picture of the breast. However, having dense breasts increases the risk for breast cancer and mammograms may not work as well to detect breast cancer. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of the breast. These pictures can show the difference between normal and tumor tissue. Recent research has shown that adding MRI to routine screening mammograms in women with dense breasts may reduce the diagnosis of breast cancer in the time between screening mammograms, but currently, there is not enough evidence for or against the recommendation to add MRI to routine screening. The Prognosia Breast model uses artificial intelligence to process mammogram images and estimate the 5-year risk of developing breast cancer. Using the Prognosia Breast MRS to identify women with dense breasts may be an effective method to determine who should have an MRI in addition to routine screening mammograms. In addition, adding MRI to routine screening mammograms may be more effective in detecting breast tumors than screening mammograms alone in women with dense breasts.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07277738.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Tabassum Ahmad
Phone: 314-474-7696
PRIMARY OBJECTIVES:
I. To determine the success rate of recommending MRI for women who have dense breasts and 5-year risk of breast cancer greater than or equal to 3% as calculated by MRS. (Feasibility study)
II. To determine the effectiveness of using breast MRS to stratify and improve efficiency for detecting interval breast cancers or invasive breast cancers that are either larger than 15 mm or are lymph node positive. (Randomized controlled trial)
SECONDARY OBJECTIVES:
I. To generate an updated sample size for the randomized controlled trial where we will evaluate the 2-year detection (occurrence) rate of either interval breast cancer or invasive breast cancer larger than 15 mm or node positive. (Feasibility study)
II. To determine the recall rate for additional testing and biopsy. (Both feasibility study and randomized controlled trial)
III. To determine the positive predictive value of recall for recall for additional testing and biopsy. (Both feasibility study and randomized controlled trial)
OUTLINE:
FEASIBILITY STUDY: Patients receive a recommendation to undergo breast MRI. Patients may undergo breast MRI over 30-60 minutes within 12 months in the absence of diagnosis of breast cancer or unacceptable toxicity. Patients may also undergo blood sample collection on study.
RANDOMIZED CONTROLLED TRIAL: Patients participate in a future randomized controlled trial following a protocol amendment submission. Patients are randomized to 1 of 2 arms.
ARM A: Patients undergo breast MRI and standard of care annual screening mammography with MRI for up to 24 months in the absence of diagnosis of breast cancer or unacceptable toxicity.
ARM B: Patients undergo standard of care annual screening mammography for up to 24 months in the absence of diagnosis of breast cancer or unacceptable toxicity.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorTabassum Ahmad
