This clinical trial offers supplemental breast magnetic resonance imaging (MRI) to screen for breast cancer in women who are determined to be at higher risk, based on a mammogram-based artificial intelligence algorithm. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Offering supplemental MRI to women who are determined to be at higher risk for developing breast cancer may improve the cancer detection rate.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07121972.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Maggie Chung
Phone: 415-885-7464
PRIMARY OBJECTIVE:
I. To estimate the cancer detection rate (CDR) of supplemental screening breast MRI in patients identified as high-risk by the Mirai model.
SECONDARY OBJECTIVES:
I. To estimate the CDR of supplemental screening breast MRI in patients with high Mirai risk and low (< 20%) lifetime Tyrer-Cuzick (TC) risk.
II. To compare the CDR of supplemental screening breast MRI in patients with high Mirai risk and high (≥ 20%) lifetime TC risk versus CDR in patients with high Mirai risk and low (< 20%) lifetime TC risk.
III. To estimate the positive predictive value (PPV)1, PPV2, and PPV3 of supplemental MRI screening in patients with high Mirai risk.
IV. To estimate the false positive rate (1 – specificity) of supplemental screening MRI in patients with high Mirai risk.
V. To evaluate the tumor size, stage, grade, histological and molecular subtypes, Ki-67 percentage, and lymph node involvement of cancers detected on supplemental screening MRI in Mirai high risk patients.
VI. To evaluate the association between race/ethnicity, menopausal status, hormonal status, breast density, family history of cancer and CDR in Mirai high risk patients.
EXPLORATORY OBJECTIVE:
I. To compare the interval cancer rate for Mirai high-risk patients who received supplemental MRI compared to historical controls (i.e. retrospective review of high risk Mirai patients who did not receive supplemental MRI) for two annual screening intervals.
II. To compare the interval cancer rate for Mirai high-risk patients who received supplemental MRI compared to Mirai high-risk patients who did not receive supplemental MRI for two annual screening intervals.
OUTLINE:
Patients undergo a supplemental MRI within 12 months of their negative standard of care (SOC) screening MRI. Patients with Breast Imaging Reporting and Data System (BI-RADS) 3 findings on supplemental MRI may undergo additional imaging (ultrasound or MRI) within 1-6 months of supplemental MRI and patients with BI-RADS 4/5 findings on supplemental MRI may undergo biopsy within 1-6 months of supplemental MRI.
After completion of study intervention, patients are followed up for 24 months after MRI.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorMaggie Chung
