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

NCT04854304 | Active Not Recruiting

• 1 other identifier: 844978
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Diseases

Keywords

Black women; dense breast

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Interventions

Fast Breast Abbreviated Magnetic Renounce Imaging DIAGNOSTIC_TEST

Fast Breast MRI Imaging

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• Patients who have not had an MRI of the breast with the past year

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

UPENN

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Emily F Conant, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 22, 2021
• Study Start: September 23, 2021
• Primary Completion (Estimated): December 13, 2027
• Study Completion (Estimated): July 13, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)