Non-contrast DWI for Supplemental Screening



Status:Enrolling by invitation
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 80
Updated:8/2/2018
Start Date:July 16, 2018
End Date:July 2028

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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.

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

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
We found this trial at
1
site
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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