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

Supplemental Screening for Breast Cancer With Abbreviated Breast MR for Black Women With Increased Breast Density

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Diseases
• Intervention / Treatment: Diagnostic test: Fast Breast Abbreviated Magnetic Renounce Imaging

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • UPenn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women who have no personal history and no family history of Breast Cancer.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast cancer detection and false negative rates of supplemental screening with AB-MR	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.	Through the completion of study, an average of 4 year
Additional screening outcomes	The rates of false positive exams prompting biopsy and short term follow-up recommendations after AB-MR will be evaluated.	Through the completion of study, an average of 4 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Through the completion of study, an average of 4 year

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Emily F Conant, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Estimated): December 13, 2027
• Study Completion (Estimated): July 13, 2028

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Black women; dense breast
• Additional Relevant MeSH Terms: Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases
• Other Study ID Numbers: 844978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No