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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04854304
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 45.6
• Patients Per Site Per Month: 11

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated 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: Sep 23, 2021
• Anticipated Primary Completion Date: Jul 13, 2024
• Anticipated Study Completion Date: Jul 13, 2025

Outcome Measures

Primary Outcome Measures

1. Breast cancer detection and false negative rates of supplemental screening with AB-MR [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 [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. [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

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	UPENN	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Apr 22, 2021
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Emily Fox Conant, Professor and Chief, Division of Breast Imaging, University of Pennsylvania: Black women; dense breast
• Additional relevant MeSH terms: Breast Diseases

Study Results

No Results Posted as of Jun 16, 2022