DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer
A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A MULTI-CENTER STUDY EVALUATING THE UTILITY OF DIFFUSION WEIGHTED IMAGING FOR DETECTION AND DIAGNOSIS OF BREAST CANCER|
- Apparent Diffusion Coefficient (ADC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Whether the Apparent Diffusion Coefficient (ADC), when used systematically in conjunction with conventional Dynamic Contrast Enhanced-Magnetic Resonance Imaging (DCE-MRI), can reduce the biopsy rate by at least 20% while maintaining sensitivity.
- Optimal ADC Cutoffs by Lesion Type [ Time Frame: 1 year ] [ Designated as safety issue: No ]Whether optimal ADC cutoffs are different for mass and non-mass lesion types;
- Local and Central Review Comparison (ADC Value Differences) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Whether site-generated ADC values differ significantly from those obtained by central review;
- Minimum B-Value for Differentiating Lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]Whether the use of a nonzero minimum b-value to reduce perfusion effects in ADC calculation can increase the area under the curve (AUC) for differentiating benign and malignant lesions;
- ADC Measurements/Ratios to Define Subject Lesion Variations [ Time Frame: 1 year ] [ Designated as safety issue: No ]Whether the use of a normalized ADC measure (tumor/normal ratio) to account for inter- and intra-subject variations in water content and other factors can increase the AUC for differentiating benign and malignant lesions;
- Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: DCE-MRI and DWI
Single arm study, diagnosis defined as BIRADS 3, 4, or 5 lesion(s) based on DCE-MRI only with DWI collected in tandem as standard practice.
Procedure: DCE-MRI and DWI
DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up
For this study, the investigators plan to evaluate DWI scans performed in women with breast lesions identified by conventional breast MRI. The investigators will determine whether an ADC threshold can be defined for distinguishing benign and malignant lesions on DWI, assess the difference in ADC cutoffs for mass and non-mass lesions, and investigate the potential improvement in accuracy using techniques such as nonzero minimum b-value (to remove perfusion effects in the ADC measures) and normalized ADC measures (to account for variations in water content and other factors).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02022579
|Contact: Savannah Partridge, PhDfirstname.lastname@example.org|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Diane Guay 206-598-9322 email@example.com|
|Principal Investigator: Savannah Partridge, PhD|
|Principal Investigator:||Savannah Partridge, PhD||University of Washington|
|Study Chair:||Habib Rahbar, MD||University of Washington|
|Study Chair:||Thomas Chenevert, PhD||University of Michigan|