- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04854304
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Isabella Strickler
- Phone Number: 313-600-3369
- Email: Isabella.Strickler@pennmedicine.upenn.edu
Study Contact Backup
- Name: Jessica Nunez
- Phone Number: 215-746-6788
- Email: jessica.nunez@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- UPenn
-
Contact:
- Isabella Strickler
- Phone Number: 313-600-3369
- Email: Isabella.Strickler@pennmedicine.upenn.edu
-
Principal Investigator:
- Emily F Conant, MD
-
Contact:
- Jessica Nunez
- Phone Number: 215-746-6788
- Email: jessica.nunez@pennmedicine.upenn.edu
-
-
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:
- 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
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
Keywords
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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