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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA080098 | U.S. NIH Grant/Contract | View source | |
| U01CA079778 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eastern Cooperative Oncology Group | NETWORK |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCE-MRI and DWI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCE-MRI and DWI | Procedure | DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up |
|
| 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 |
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Savannah Partridge, PhD | University of Washington | Principal Investigator |
| Habib Rahbar, MD | University of Washington | Study Chair |
| Thomas Chenevert, PhD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33201788 | Derived | McDonald ES, Romanoff J, Rahbar H, Kitsch AE, Harvey SM, Whisenant JG, Yankeelov TE, Moy L, DeMartini WB, Dogan BE, Yang WT, Wang LC, Joe BN, Wilmes LJ, Hylton NM, Oh KY, Tudorica LA, Neal CH, Malyarenko DI, Comstock CE, Schnall MD, Chenevert TL, Partridge SC. Mean Apparent Diffusion Coefficient Is a Sufficient Conventional Diffusion-weighted MRI Metric to Improve Breast MRI Diagnostic Performance: Results from the ECOG-ACRIN Cancer Research Group A6702 Diffusion Imaging Trial. Radiology. 2021 Jan;298(1):60-70. doi: 10.1148/radiol.2020202465. Epub 2020 Nov 17. |
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see ACRIN data sharing policy : https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2023 | |
| Reset | Jul 25, 2023 | |
| Release | Nov 29, 2023 | |
| Reset | Dec 21, 2023 | |
| Release | Mar 18, 2024 | |
| Reset | Apr 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2023 | Jul 25, 2023 | |||
| Nov 29, 2023 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 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 |
| Dec 21, 2023 |
| Mar 18, 2024 | Apr 5, 2024 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |