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Non-contrast DWI for Supplemental Screening

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ClinicalTrials.gov Identifier: NCT03607552
Recruitment Status : Active, not recruiting
First Posted : July 31, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
University of Washington

Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Device: Non-contrast DWI Device: Non-contrast MRI

Detailed 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

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Study Type : Observational
Estimated Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-contrast DWI for Supplemental Screening of Women With Dense Breasts
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Phase 1: Pilot Study Phase
Optimize DWI sequences to maximize spatial resolution, reduce distortion, and increase lesion contrast.
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.

Phase 2: Development Phase
Develop interpretation tools to optimize diagnostic performance for detecting cx on DWI.
Device: Non-contrast MRI
Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women age 18+, with mammographically identified dense breasts, referred for clinical breast MRI
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607552


Locations
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United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03607552     History of Changes
Other Study ID Numbers: 9785
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Washington:
Supplemental Screening
Dense Breasts
Diffusion Weighted Imaging