Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04854304

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

UPENN

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast Breast Abbreviated Magnetic Renounce Imaging

Diagnostic Test

Fast Breast MRI Imaging

Primary outcomes

  1. 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.

  2. 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.

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.

    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

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2021
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.