Non-contrast DWI for Supplemental Screening

Status Active, not recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Breast Cancer

Clinical Trial Details

NCT number	NCT03607552
Study type	Observational
Source	University of Washington
Contact
Status	Active, not recruiting
Phase
Start date	July 16, 2018
Completion date	July 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.