BIRADS 3, BIRADS 4, BIRADS 5, Breast Cancer
Conditions
Keywords
Breast Cancer, Diagnosis, Malignant, Benign, Biopsy
Brief summary
A type of magnetic resonance imaging called diffusion weighted imaging (DWI) will be tested to define cancerous from non-cancerous lesions in the breast.
Detailed description
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).
Interventions
PROCEDUREDCE-MRI and DWI
DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
American College of Radiology Imaging Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Diffusion Coefficient (ADC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimal ADC Cutoffs by Lesion Type | 1 year | Whether optimal ADC cutoffs are different for mass and non-mass lesion types; |
| Local and Central Review Comparison (ADC Value Differences) | 1 year | Whether site-generated ADC values differ significantly from those obtained by central review; |
| Minimum B-Value for Differentiating Lesions | 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 | 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) | 1 year | Whether ADC with nonzero minimum b-value and/or normalized ADC can reduce the biopsy rate while maintaining sensitivity. |
Countries
United States
Outcome results
None listed