Status:
ACTIVE_NOT_RECRUITING
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Healthy Subject
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 com...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2026
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT03303846
Start Date
October 13 2017
End Date
April 25 2026
Last Update
April 11 2025
Active Locations (5)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of Southern California
Los Angeles, California, United States, 90033
3
Duke University
Durham, North Carolina, United States, 27705
4
Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212