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

Breast Diseases Clinical Trial

Official title:

Supplemental Screening for Breast Cancer With Abbreviated Breast MR for Black Women With Increased Breast Density

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04854304
• Other study ID #: 844978
• Status: Recruiting
• Start date: September 23, 2021
• Est. completion date: July 13, 2025

Study information

• Verified date: July 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Jessica Nunez
• Phone: 215-746-6788
• Email: Jessica.Nunez[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 13, 2025
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Diseases

Intervention

Diagnostic Test:
• Fast Breast Abbreviated Magnetic Renounce Imaging
Fast Breast MRI Imaging

Locations

Country	Name	City	State
United States	UPENN	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through the completion of study, an average of 4 year
Primary	Additional screening outcomes	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	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	Through the completion of study, an average of 4 year