Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average… (NCT04854304) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts
United States500 participantsStarted 2021-09-23
Plain-language summary
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. African American 2. negative DBT examination 11 months prior to recruitment 3. Heterogeneously and Extremely breast densities 4. clinically asymptomatic- no palpable masses, focal thickening or clinically significant discharge. Investigators will identify these patients EPIC database utilizing the date of their last mammogram. Interested patients may contact our research coordinators by the phone number provided in the recruitment materials. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.
Who can participate
Age range40 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. African American female
✓. Negative DBT examination within eleven months prior to recruitment
✓. Heterogeneoulsy and Extremely breast densities
✓. Clinically asymptomatic- no palpable masses or focal thickening, etc.
Exclusion criteria
✕. Patients who are pregnant and lactating
✕. Patient who have not had a mammogram (DBT) in the past 11months
✕. Patients who are unwilling or unable to provide written informed consent
✕. Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, ect.)
✕. Recent breast surgery in the past 2 years including breast enhancements (e.g. implants or injections)
✕. Patients who are unable to received an MRI with Gadolinium contrast
What they're measuring
1
Breast cancer detection and false negative rates of supplemental screening with AB-MR
Timeframe: Through the completion of study, an average of 4 year
2
Additional screening outcomes
Timeframe: Through the completion of study, an average of 4 year