Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts

Recruiting

• Conditions: Breast Diseases

• Registration Number: NCT04854304
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief 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.

Detailed Description

500 patients will be prospectively recruited to undergo an abbreviated or "FAST" breast MRI examination. The women will be recruited for the study must meet the following criteria: 1. African American 2. negative DBT examination no more than 11 months prior to the FAST MR 3. Heterogeneously and Extremely breast densities as graded on their most recent mammogram 4. clinically asymptomatic- no palpable masses, focal thickening or clinically significant nipple discharge. Investigators will identify these women via the EPIC database utilizing the date of their last mammogram. Interested women 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.

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-16
• Study First Posted: 2021-04-22
• Study Start: 2021-09-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-07-13
• Study Completion: 2026-07-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. African American female
2. Negative DBT examination within eleven months prior to recruitment
3. Heterogeneoulsy and Extremely breast densities
4. Clinically asymptomatic- no palpable masses or focal thickening, etc.

Exclusion Criteria

1. Patients who are pregnant and lactating
2. Patient who have not had a mammogram (DBT) in the past 11months
3. Patients who are unwilling or unable to provide written informed consent
4. Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, ect.)
5. Recent breast surgery in the past 2 years including breast enhancements (e.g. implants or injections)
6. Patients who are unable to received an MRI with Gadolinium contrast
7. Patients who have not had an MRI of the breast with the past year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breast cancer detection and false negative rates of supplemental screening with AB-MR	Through the completion of study, an average of 4 year	The cancer detection and false negative rate (per 1000 women screened) of supplemental screening with AB-MR in this population will be measured as well as the stage, grade and subtype of detected and non-detected breast cancers.
Additional screening outcomes	Through the completion of study, an average of 4 year	The rates of false positive exams prompting biopsy and short term follow-up recommendations after AB-MR will be evaluated.

Secondary Outcome Measures

Name	Time	Method
The screening outcomes of AB-MR in this population of Black women will be compared to a similar population of Caucasian women undergoing AB-MR.	Through the completion of study, an average of 4 year	The cancer detection, false negative and false positive rates as well as stage and subtypes of cancers will be compared to a similar population of Caucasian women screened with AB-MR

Trial Locations

Locations (1)

UPENN; 🇺🇸 Philadelphia, Pennsylvania, United States