Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03607552

Non-contrast DWI for Supplemental Screening

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Oregon Health & Science University, Portland, Oregon, United States

Loading trial locations.

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 or older
  • Dense breast identified on mammogram

Exclusion criteria

  • 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

Treatment and study plan

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.

Non-contrast MRI

Device

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

Primary outcomes

  1. Diffusion sensitization (b value)

    Time frame: 2.5 years

    Identify optimal b value to maximize conspicuity of cancers in women with dense breasts

  2. Reader Interpretation strategy

    Time frame: 3.5 years

    Identify optimal ADC thresholds to differentiate malignant from benign lesions

  3. Specificity

    Time frame: 4.5 years

    Specificity will be assessed for non-contrast DWI

  4. Sensitivity

    Time frame: 4.5 years

    Sensitivity will be assessed for non-contrast DWI

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2029
First posted
Jul 31, 2018
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.