Non-contrast DWI for Supplemental Screening

Breast Cancer Clinical Trial

Official title:

Non-contrast DWI for Supplemental Screening of Women With Dense Breasts

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03607552
• Other study ID #: 9785
• Secondary ID: RG3017005R01CA20
• Status: Active, not recruiting
• Start date: July 16, 2018
• Est. completion date: July 2028

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 269
• Est. completion date: July 2028
• Est. primary completion date: September 2025
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Non-contrast DWI
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
Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion sensitization (b value)	Identify optimal b value to maximize conspicuity of cancers in women with dense breasts	2.5 years
Primary	Reader Interpretation strategy	Identify optimal ADC thresholds to differentiate malignant from benign lesions	3.5 years
Primary	Specificity	Specificity will be assessed for non-contrast DWI	4.5 years
Primary	Sensitivity	Sensitivity will be assessed for non-contrast DWI	4.5 years