An interventional study of DCE-MRI and DWI in Breast Cancer, BIRADS 3 and BIRADS 4, sponsored by American College of Radiology Imaging Network. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-11.
Sponsored by American College of Radiology Imaging Network · Not applicable, Interventional, and Diagnostic
A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.
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).
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →American College of Radiology Imaging Network is the lead sponsor of 22 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Also known as: magnetic resonance imaging, MRI, DCE-MRI, DWI, DW-MRI
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.
Time frame: 1 year
Optimal ADC Cutoffs by Lesion Type
Whether optimal ADC cutoffs are different for mass and non-mass lesion types;
Time frame: 1 year
Local and Central Review Comparison (ADC Value Differences)
Whether site-generated ADC values differ significantly from those obtained by central review;
Time frame: 1 year
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;
Time frame: 1 year
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;
Time frame: 1 year
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.
Time frame: 1 year
Plan to share: Yes — see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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American College of Radiology Imaging Network