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

• ClinicalTrials.gov Identifier: NCT04854304
• Recruitment Status: Recruiting
• First Posted: April 22, 2021
• Last Update Posted: June 16, 2022
• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Information provided by (Responsible Party): Emily Fox Conant, University of Pennsylvania

Tracking Information

• First Submitted Date: April 8, 2021
• First Posted Date: April 22, 2021
• Last Update Posted Date: June 16, 2022
• Actual Study Start Date: September 23, 2021
• Estimated Primary Completion Date: July 13, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2021)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 16, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts
• Official Title: Supplemental Screening for Breast Cancer With Abbreviated Breast MR for Black Women With Increased Breast Density
• 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.
• 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
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Women who have no personal history and no family history of Breast Cancer.
• Condition: Breast Diseases

Intervention

Diagnostic Test: Fast Breast Abbreviated Magnetic Renounce Imaging

Fast Breast MRI Imaging

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 16, 2021): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 13, 2025
• Estimated Primary Completion Date: July 13, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: female at birth

• Ages: 40 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Jessica Nunez; 215-746-6788; Jessica.Nunez@pennmedicine.upenn.edu

Contact: Isabella Strickler; 313-600-3369; Isabella.Strickler@pennmedicine.upenn.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04854304
• Other Study ID Numbers: 844978
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Emily Fox Conant, University of Pennsylvania
• Original Responsible Party: Emily Conant, MD, University of Pennsylvania, Professor and Chief, Division of Breast Imaging
• Current Study Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Original Study Sponsor: University of Pennsylvania
• Collaborators: Not Provided

Investigators

• Principal Investigator: Emily F Conant, MD; University of Pennsylvania

• PRS Account: Abramson Cancer Center of the University of Pennsylvania
• Verification Date: June 2022