Breast Cancer Clinical Trial
— ACRIN6702Official title:
A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer
Verified date | October 2018 |
Source | American College of Radiology Imaging Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | March 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Willing and able to provide written informed consent; - 18 years of age or older; - Successful completion of breast MR examination with DWI required by protocol; - Undiagnosed breast lesion (BI-RADS 3, 4, or 5) identified on MRI. The BI-RADS assessment must refer to a focal finding within the breast (i.e. mass, non-mass, or focus) as opposed to diffuse processes (e.g. background parenchymal enhancement, skin thickening) or lesions outside the subcutaneous breast (e.g. axillary lymph nodes, focal skin lesions, osseous lesions, etc.). Exclusion Criteria: - Participants with current or recent history (within 6 months prior to the MRI) of chemotherapy for cancer; - Neoadjuvant chemotherapy between MRI and confirmation of lesion outcome (study lesions must be biopsied prior to undergoing any chemotherapy); - Pregnant (if a female is of childbearing potential - defined as a pre-menopausal female capable of becoming pregnant - confirmation of pregnancy status per the site's standard of practice should be done prior to MRI); - Unwilling or not suitable to undergo MRI or use the contrast agent gadolinium. |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
American College of Radiology Imaging Network | Eastern Cooperative Oncology Group, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apparent Diffusion Coefficient (ADC) | 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. | 1 year | |
Secondary | Optimal ADC Cutoffs by Lesion Type | Whether optimal ADC cutoffs are different for mass and non-mass lesion types; | 1 year | |
Secondary | Local and Central Review Comparison (ADC Value Differences) | Whether site-generated ADC values differ significantly from those obtained by central review; | 1 year | |
Secondary | Minimum B-Value for Differentiating Lesions | 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; | 1 year | |
Secondary | ADC Measurements/Ratios to Define Subject Lesion Variations | 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; | 1 year | |
Secondary | Combination Variables (ADC Nonzero Minimum B-Value and/or Normalized ADC) | Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity. | 1 year |
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