DCE-MRI and DWI for Detection and Diagnosis of Breast Cancer

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Multi-Center Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer

Conditions
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Breast Cancer, BIRADS 3, BIRADS 4, BIRADS 5

Intervention / Treatment
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* Procedure: DCE-MRI and DWI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCE-MRI and DWI<br>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<br>* DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up<br>* Other names: DW-MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal ADC Cutoffs by Lesion Type | Whether optimal ADC cutoffs are different for mass and non-mass lesion types; | 1 year | 
| Local and Central Review Comparison (ADC Value Differences) | Whether site-generated ADC values differ significantly from those obtained by central review; | 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; | 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; | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign, Diagnosis, Breast Cancer, Malignant, Biopsy