Non-Contrast DWI for Breast Cancer Screening in Women with Dense Breasts

Status: closed to accrual

This study investigates how well diffusion-weighted imaging (DWI) works in identifying breast cancer in women with dense breasts. DWI is a short non-contrast magnetic resonance imaging (MRI) technique that may detect and characterize breast cancer in women with dense breasts. Adding DWI MRI to conventional mammography may help to improve the early detection of breast cancer not visible on standard mammography. This MRI may identify additional areas in either breast that represent a breast cancer (true positives). The purpose of this study is to see if new MRI imaging techniques can lead to earlier detection of breast cancer in women with dense breasts.

Inclusion Criteria

Women aged 18 or older
Dense breast identified on mammogram or prior MRI
AIM 1: PILOT STUDY PHASE
COHORT 1: Referred for breast MRI for extent of disease (for new cancer diagnosis)
AIM 2: DEVELOPMENTAL STUDY PHASE
COHORT 2: Referred for breast biopsy based on suspicious imaging findings in either breast (Breast Imaging Reporting and Data System [BI-RADS] 4 or 5)
AIM 3: READER PERFORMANCE PHASE
COHORT 3: Referred for breast biopsy based on suspicious imaging findings (BI-RADS 4 or 5) in either breast and no known ipsilateral (same side) cancer
COHORT 4 (CONTROLS): Referred for breast MRI for high risk screening

Exclusion Criteria

Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with glomerular filtration rate [GFR] < 60, contrast allergy, incompatible metal)
Patients who currently are undergoing systemic therapy for breast cancer or chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
Women who are pregnant

PRIMARY OBJECTIVES:

I. Improve the breast DWI technique to maximize spatial resolution, reduce distortion, and increase lesion contrast.

II. Develop interpretation tools to optimize diagnostic performance for detecting cancer on DWI.

III. Test the performance of the optimized DWI approach for detecting clinically and mammographically-occult cancer in women with dense breasts.

OUTLINE:

Patients undergo MRI imaging including DWI MRI over 60 minutes. Patients' breast imaging medical record is reviewed up to 5 years.

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Non-Contrast DWI for Breast Cancer Screening in Women with Dense Breasts

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