Non-contrast DWI for Supplemental Screening

Non-contrast DWI for Supplemental Screening of Women With Dense Breasts

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Non-contrast DWI; Device: Non-contrast MRI

Detailed Description

Hypothesis: With technical optimizations, non-contrast DWI can detect clinically and mammographically occult breast cancer in women with dense breasts with high sensitivity and low false positive rate.

Aim 1: Improve the breast DWI technique to maximize spatial resolution, reduce distortion, and increase lesion contrast.

• Develop novel DWI acquisition to increase spatial resolution and reduce distortion (using reduced field of-view and/or multishot echo planar imaging techniques)
• Identify optimal diffusion sensitization (b-value) to maximize conspicuity of cancers in women with dense breasts

Aim 2: Develop interpretation tools to optimize diagnostic performance for detecting cancer on DWI.

• Determine quantitative DWI thresholds (contrast-to-noise ratio, apparent diffusion coefficient [ADC]) that best differentiate benign and malignant lesions (i.e. maximize sensitivity and specificity)
• Develop computer aided assessment tools to facilitate clinical implementation and optimize reader accuracy

Aim 3: Test the performance of the optimized DWI approach for detecting clinically and mammographically-occult cancer in women with dense breasts.

• Conduct a controlled reader study of non-contrast DWI alone for breast cancer detection
• Perform receiver operating characteristic (ROC) analysis and determine the sensitivity and specificity for detection of mammographically occult cancer

• Study Type: Observational
• Enrollment (Actual): 269

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women age 18+, with mammographically identified dense breasts, referred for clinical breast MRI

Description

Inclusion Criteria:

1. Women aged 18 or older
2. Dense breast identified on mammogram

Exclusion Criteria:

1. Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR<60, contrast allergy, incompatible metal)
2. Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
3. Women who are pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase 1: Pilot Study Phase; Optimize DWI sequences to maximize spatial resolution, reduce distortion, and increase lesion contrast.	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.
Phase 2: Development Phase; Develop interpretation tools to optimize diagnostic performance for detecting cx on DWI.	Device: Non-contrast MRI; Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.
Phase 3: Reader Performance Phase; Test the performance of the optimized DWI approach for detecting clinically and mammographically-occult cancer in women with dense breasts.	Device: Non-contrast MRI; Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diffusion sensitization (b value)	Identify optimal b value to maximize conspicuity of cancers in women with dense breasts	2.5 years
Reader Interpretation strategy	Identify optimal ADC thresholds to differentiate malignant from benign lesions	3.5 years
Specificity	Specificity will be assessed for non-contrast DWI	4.5 years
Sensitivity	Sensitivity will be assessed for non-contrast DWI	4.5 years

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Savannah Partridge, Fred Hutch/University of Washington Cancer Consortium

Publications and helpful links

General Publications

• Biswas D, Hippe DS, Wang Y, DelPriore MR, Zecevic M, Scheel JR, Rahbar H, Partridge SC. Accelerated Breast Diffusion-weighted Imaging Using Multiband Sensitivity Encoding with the CAIPIRINHA Method: Clinical Experience at 3 T. Radiol Imaging Cancer. 2022 Jan;4(1):e210063. doi: 10.1148/rycan.210063.
• Ha SM, Chang JM, Lee SH, Kim ES, Kim SY, Kim YS, Cho N, Moon WK. Detection of Contralateral Breast Cancer Using Diffusion-Weighted Magnetic Resonance Imaging in Women with Newly Diagnosed Breast Cancer: Comparison with Combined Mammography and Whole-Breast Ultrasound. Korean J Radiol. 2021 Jun;22(6):867-879. doi: 10.3348/kjr.2020.1183. Epub 2021 Apr 1.
• Oviedo F, Kazerouni AS, Liznerski P, Xu Y, Hirano M, Vandermeulen RA, Kloft M, Blum E, Alessio AM, Li CI, Weeks WB, Dodhia R, Lavista Ferres JM, Rahbar H, Partridge SC. Cancer Detection in Breast MRI Screening via Explainable AI Anomaly Detection. Radiology. 2025 Jul;316(1):e241629. doi: 10.1148/radiol.241629.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Dense Breasts; Supplemental Screening; Diffusion Weighted Imaging
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 9785; RG3017005 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); R01CA207290 (U.S. NIH Grant/Contract); NCI-2020-05585 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No