Breast DiseasesNCT04854304
Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts
An observational study of Breast Diseases, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Diseases
- What is being tested?
- Fast Breast Abbreviated Magnetic Renounce Imaging
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2021to 13 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who have no personal history and no family history of Breast Cancer.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Breast Diseases
- Being tested
- Fast Breast Abbreviated Magnetic Renounce Imaging
- Keywords
- Black women, dense breast
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Breast Abbreviated Magnetic Renounce ImagingDiagnostic test
Fast Breast MRI Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Through the completion of study, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start23 Sep 2021
- Primary completion13 Dec 2027 (estimated)
- Study completion13 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseasesStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily F Conant, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854304
- Sponsor's protocol ID
- 844978
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplemental Screening for Breast Cancer With Abbreviated Breast MR for Black Women With Increased Breast Density
- ClinicalTrials.gov ID
- NCT04854304
- Acronym / sponsor ID
- 844978
- Conditions
- Breast Diseases
- Keywords
- Black women, dense breast
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 13 Dec 2027 (estimated)
- Study completion
- 13 Jul 2028 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have no personal history and no family history of Breast Cancer.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast Breast Abbreviated Magnetic Renounce ImagingFast Breast MRI Imaging | Diagnostic test | – |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily F Conant, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Diseases, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.