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NCT03303846
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
Conditions: Healthy Subject
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 344
Sponsor: City of Hope Medical Center
Location: City of Hope Medical Center Duarte California
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 combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT03303846). StuddyBuddy aggregates publicly available trial information.