Breast CancerNCT03607552
Non-contrast DWI for Supplemental Screening
An observational study of Breast Cancer, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Non-contrast DWI and Non-contrast MRI
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 269 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2018to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Adult, Older adult
Study population: Women age 18+, with mammographically identified dense breasts, referred for clinical breast MRI
Who may be able to join
- Women aged 18 or older
- Dense breast identified on mammogram
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Health & Science University
Portland, Oregon, 97239
Seattle Cancer Care Alliance
Seattle, Washington, 98109
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Non-contrast DWI, Non-contrast MRI
- Keywords
- Supplemental Screening, Dense Breasts, Diffusion Weighted Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast DWIDevice
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 MRIDevice
Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Pilot Study Phase | Optimize DWI sequences to maximize spatial resolution, reduce distortion, and increase lesion contrast. Receives: Device: Non-contrast DWI | |
| Phase 2: Development Phase | Develop interpretation tools to optimize diagnostic performance for detecting cx on DWI. Receives: 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. Receives: Device: Non-contrast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion sensitization (b value)
Identify optimal b value to maximize conspicuity of cancers in women with dense breasts
Measured: 2.5 years
Reader Interpretation strategy
Identify optimal ADC thresholds to differentiate malignant from benign lesions
Measured: 3.5 years
Specificity
Specificity will be assessed for non-contrast DWI
Measured: 4.5 years
Sensitivity
Sensitivity will be assessed for non-contrast DWI
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start16 Jul 2018
- Primary completionSep 2026 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Savannah Partridge, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607552
- Sponsor's protocol ID
- 9785
- Other IDs
- RG3017005, R01CA207290, NCI-2020-05585
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40662973Biswas 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.
PubMed 35029517Ha 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.
PubMed 33856137
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-contrast DWI for Supplemental Screening of Women With Dense Breasts
- ClinicalTrials.gov ID
- NCT03607552
- Acronym / sponsor ID
- 9785
- Conditions
- Breast Cancer
- Keywords
- Supplemental Screening, Dense Breasts, Diffusion Weighted Imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 269 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Pilot Study Phase | – | Device: Non-contrast DWIOptimize DWI sequences to maximize spatial resolution, reduce distortion, and increase lesion contrast. |
| Phase 2: Development Phase | – | Device: Non-contrast MRIDevelop interpretation tools to optimize diagnostic performance for detecting cx on DWI. |
| Phase 3: Reader Performance Phase | – | Device: Non-contrast MRITest the performance of the optimized DWI approach for detecting clinically and mammographically-occult cancer in women with dense breasts. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women age 18+, with mammographically identified dense breasts, referred for clinical breast MRI
Key inclusion criteria (2 listed)
- Women aged 18 or older
- Dense breast identified on mammogram
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-contrast DWIDiffusion-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 | Phase 1: Pilot Study Phase |
| Non-contrast MRINon-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences. | Device | Phase 2: Development Phase, Phase 3: Reader Performance Phase |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40662973Oviedo 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.
- Derived from this study: PubMed 35029517Biswas 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.
- Derived from this study: PubMed 33856137Ha 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Savannah Partridge principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion sensitization (b value) (time frame: 2.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607552, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.