DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer (ACRIN6702)
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|ClinicalTrials.gov Identifier: NCT02022579|
Recruitment Status : Unknown
Verified October 2018 by American College of Radiology Imaging Network.
Recruitment status was: Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : October 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer BIRADS 3 BIRADS 4 BIRADS 5||Procedure: DCE-MRI and DWI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||March 2019|
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
- Apparent Diffusion Coefficient (ADC) [ Time Frame: 1 year ]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 ]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 ]Whether site-generated ADC values differ significantly from those obtained by central review;
- Minimum B-Value for Differentiating Lesions [ Time Frame: 1 year ]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 ]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 ]Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity.
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): NCT02022579
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Savannah Partridge, PhD||University of Washington|
|Study Chair:||Habib Rahbar, MD||University of Washington|
|Study Chair:||Thomas Chenevert, PhD||University of Michigan|