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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04854304
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
Emily Fox Conant, University of Pennsylvania

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Breast Diseases Diagnostic Test: Fast Breast Abbreviated Magnetic Renounce Imaging

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
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Supplemental Screening for Breast Cancer With Abbreviated Breast MR for Black Women With Increased Breast Density
Actual Study Start Date : September 23, 2021
Estimated Primary Completion Date : July 13, 2024
Estimated Study Completion Date : July 13, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Fast Breast Abbreviated Magnetic Renounce Imaging
    Fast Breast MRI Imaging

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female at birth
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women who have no personal history and no family history of Breast Cancer.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854304


Contacts
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Contact: Jessica Nunez 215-746-6788 Jessica.Nunez@pennmedicine.upenn.edu
Contact: Isabella Strickler 313-600-3369 Isabella.Strickler@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
UPENN Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica Nunez    215-746-6788    Jessica.Nunez@pennmedicine.upenn.edu   
Contact: Isabella Strickler    313-600-3369    Isabella.Strickler@pennmedicine.upenn.edu   
Principal Investigator: Emily F Conant, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Emily F Conant, MD University of Pennsylvania
More Information
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Responsible Party: Emily Fox Conant, Professor and Chief, Division of Breast Imaging, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04854304    
Other Study ID Numbers: 844978
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emily Fox Conant, University of Pennsylvania:
Black women
dense breast
Additional relevant MeSH terms:
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Breast Diseases
Skin Diseases