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| ID | Type | Description | Link |
|---|---|---|---|
| RG3017005 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA207290 | U.S. NIH Grant/Contract | View source | |
| NCI-2020-05585 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
Aim 2: Develop interpretation tools to optimize diagnostic performance for detecting cancer on DWI.
Aim 3: Test the performance of the optimized DWI approach for detecting clinically and mammographically-occult cancer in women with dense breasts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Pilot Study Phase | Optimize DWI sequences to maximize spatial resolution, reduce distortion, and increase lesion contrast. |
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| Phase 2: Development Phase | Develop interpretation tools to optimize diagnostic performance for detecting cx on DWI. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women age 18+, with mammographically identified dense breasts, referred for clinical breast MRI
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| Name | Affiliation | Role |
|---|---|---|
| Savannah Partridge | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States | ||
| Seattle Cancer Care Alliance |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40662973 | Derived | 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. | |
| 35029517 | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Non-contrast MRI | Device | Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences. |
|
| Seattle |
| Washington |
| 98109 |
| United States |
| 33856137 | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |