Non-contrast DWI for Supplemental Screening

NCT03607552 | Active Not Recruiting FDA Device

• 4 other identifiers: 9785RG3017005R01CA207290NCI-2020-05585
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 2

Brief 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

Breast Cancer

Keywords

Supplemental Screening; Dense Breasts; Diffusion Weighted Imaging

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Phase 1: Pilot Study Phase

Optimize DWI sequences to maximize spatial resolution, reduce distortion, and increase lesion contrast.

Device: Non-contrast DWI

Phase 2: Development Phase

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

Device: Non-contrast MRI

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

Interventions

Non-contrast DWI DEVICE

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 1: Pilot Study Phase

Non-contrast MRI DEVICE

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

Phase 2: Development Phase; Phase 3: Reader Performance Phase

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Women aged 18 or older
• Dense breast identified on mammogram

You may not qualify if:

• Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Washington: lead

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Related Publications (3)

• 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.

  PMID: 40662973 DERIVED

• 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.

  PMID: 35029517 DERIVED

• 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.

  PMID: 33856137 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Savannah Partridge

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: July 31, 2018
• Study Start: July 16, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)