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Active, not recruitingNCT04854304Updated Jan 15, 2026

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

An observational study in Breast Diseases, sponsored by Abramson Cancer Center at Penn Medicine. Active, not recruiting at 1 site in United States. Open to female participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by Abramson Cancer Center at Penn Medicine · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
500
Ages
40 Years to 75 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Diseases

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Keywords

  • Black women
  • dense breast
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In context

Breast Diseases

149 studies on the registry are indexed under Breast Diseases; 25 are open to participants now.

This study's planned enrollment of 500 is above the median of 225 across 55 observational studies indexed under Breast Diseases.

Browse Breast Diseases studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testFast Breast Abbreviated Magnetic Renounce Imaging

    Fast Breast MRI Imaging

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through the completion of study, an average of 4 year

  2. Additional screening outcomes

    The rates of false positive exams prompting biopsy and short term follow-up recommendations after AB-MR will be evaluated.

    Time frame: 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.

    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

    Time frame: Through the completion of study, an average of 4 year

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Study locations

1 site
  • UPENN
    Philadelphia, Pennsylvania 19104, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04854304
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Apr 22, 2021
Start date
Sep 23, 2021
Primary completion
Dec 13, 2027 (estimated)
Completion
Jul 13, 2028 (estimated)
Last update
Jan 15, 2026

Study contacts

Emily F Conant, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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