Non-contrast DWI for Supplemental Screening
Breast Cancer
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 80 years
- Sex eligible
- Female
- Healthy volunteers
- Not reported
- Participants
- 269 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full 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
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 population
Women age 18+, with mammographically identified dense breasts, referred for clinical breast MRI
Understand screeningTreatment, groups and participation
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- Assignment
- Not reported
- Masking
- Not reported
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
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.
Non-contrast MRI DEVICE
Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Diffusion sensitization (b value)
Time frame: 2.5 years
Identify optimal b value to maximize conspicuity of cancers in women with dense breasts
Reader Interpretation strategy
Time frame: 3.5 years
Identify optimal ADC thresholds to differentiate malignant from benign lesions
Specificity
Time frame: 4.5 years
Specificity will be assessed for non-contrast DWI
Sensitivity
Time frame: 4.5 years
Sensitivity will be assessed for non-contrast DWI
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (2)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
2 locations
Oregon Health & Science UniversityPortland, Oregon, United StatesStatus unknown
Seattle Cancer Care AllianceSeattle, Washington, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- University of Washington
- Study start
- Jul 16, 2018 Actual
- Primary completion
- 2027-07 Estimated
- Study completion
- 2029-07 Estimated
- First posted
- Jul 31, 2018 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Non-contrast DWI for Supplemental Screening of Women With Dense Breasts
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026