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

July 18, 2023 updated by: Emily Fox Conant, Abramson Cancer Center at Penn Medicine

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 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.
Through the completion of study, an average of 4 year
Additional screening outcomes
Time Frame: 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.
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.
Time Frame: 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
Through the completion of study, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emily F Conant, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2021

Primary Completion (Estimated)

July 13, 2024

Study Completion (Estimated)

July 13, 2025

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)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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