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Non-contrast DWI for Supplemental Screening

NCT03607552 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 269

Last updated 2026-05-05

No results posted yet for this study

Summary

Diffusion-weighted imaging (DWI) is a short (under 5 minutes) non-contrast MRI technique that has shown promise for the detection and characterization of breast cancer. Our preliminary data has shown that DWI holds potential for detecting mammographically and clinically-occult breast cancers. However, current technical limitations reduce the sensitivity of DWI for screening applications.

The identification of a screening tool to complement mammography that is more accurate than ultrasound and faster, less expensive, and safer than conventional contrast-enhanced MRI would have significant clinical impact by improving the early detection of cancer in women with dense breasts. We hypothesize that an optimized DWI approach will enable detection of mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.

Conditions

Interventions

DEVICE

Non-contrast DWI

Diffusion-weighted imaging (DWI) is a non-contrast MRI technique that typically can be acquired in under 5 minutes. DWI reflects the microscopic cellular environment and can demonstrate differences between normal and malignant breast tissue without the aid of intravenous gadolinium.

DEVICE

Non-contrast MRI

Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.

Sponsors & Collaborators

Principal Investigators

  • Savannah Partridge · Fred Hutch/University of Washington Cancer Consortium

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2026-09-30
Completion
2029-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03607552 on ClinicalTrials.gov