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NCT04854304 | RECRUITING | Breast Diseases

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

Abramson Cancer Center at Penn Medicine

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

Breast Diseases

Intervention/treatment

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 Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : Supplemental Screening for Breast Cancer With Abbreviated Breast MR for Black Women With Increased Breast Density
Actual Study Start Date : 2021-09-23
Estimated Primary Completion Date : 2025-07-13
Estimated Study Completion Date : 2026-07-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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
Abbreviate or FAST Breast MRI for Supplemental Breast Cancer Screening for Black Women at Average Risk and Dense Breasts

Location Details

NCT04854304

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Pennsylvania

Upenen

Philadelphia, Pennsylvania, United States, 19104