Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

Running, not enrolling · Not applicable

Conditions studied: Healthy Subject

In brief

This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.

Key facts

Study ID

NCT03303846

Run by

City of Hope Medical Center

People needed

344

Starts

2017-10-13

Expected to finish

2026-11-20

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
• Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
• Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
• Documented informed consent of the participant

You may not qualify if…

• Allergy or intolerance to gadolinium
• Inability to undergo breast MRI (e.g. claustrophobia)
• Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
• Previous diagnosis of stage 4 cancer
• Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
• Participants who have received endocrine therapy within 1 year prior to screening breast MRI
• Participants who have received breast radiation within 1 year prior to screening breast MRI
• Radiation to both breasts
• Pregnant and/or lactating within 1 year prior to screening breast MRI
• Receives screening breast MRIs at an outside facility other than the consenting institution

Where it is running

• City of Hope Medical Center — Duarte, California, United States
• University of Southern California — Los Angeles, California, United States
• Duke University — Durham, North Carolina, United States
• Ohio State University, Stefanie Spielman Comprehensive Breast Center — Columbus, Ohio, United States
• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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