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

Trial Status: Active

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 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

  • Dense breast identified on mammogram
  • PHASE 1: PILOT STUDY PHASE
  • COHORT 1: Referred for breast MRI for * Extent of Disease (for new cancer diagnosis)
  • PHASE 2: DEVELOPMENTAL STUDY PHASE
  • COHORT 2: Women age 18+ with * Mammographically identified dense breasts, * Referred for breast biopsy based on suspicious imaging findings in either breast (Breast Imaging Reporting and Data System [BI-RADS] 4 or 5)
  • PHASE 3: READER PERFORMANCE PHASE
  • COHORT 3: Women age 18+ with * Mammographically identified dense breasts, * 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): Women age 18+ with * Mammographically identified dense breasts * Referred for breast MRI

Exclusion Criteria

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

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Contact: Savannah Corrina Partridge
Phone: 206-606-1306
Email: scp3@uw.edu

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.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
Fred Hutch / University of Washington Cancer Consortium

Principal Investigator
Savannah Corrina Partridge

  • Primary ID RG3017005
  • Secondary IDs NCI-2020-05585, 9785
  • Clinicaltrials.gov ID NCT03607552