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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA203883 | U.S. NIH Grant/Contract | View source | |
| RG3017004 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| NCI-2021-12034 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This is a single institution, prospective observational clinical trial for women with mammographically identified calcifications that may represent ductal carcinoma in situ (DCIS).
The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to surgical resection can biologically characterize this common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.
The investigators will assess whether MRI signatures can determine which calcifications identified prior to surgical resection actually harbor DCIS, and whether these imaging features correlate with pathologic markers of proliferation (Ki-67) and inflammation (cox-2) within DCIS lesions.
The investigators will also explore whether quantitative MRI features in the peri-tumoral region correlate with prognostic microenvironment markers of inflammation (TNFα) and angiogenesis (VEGF). Finally, investigators will assess whether a multivariate model using these markers can accurately predict risk of recurrence based on a multi-gene assay (Oncotype DX DCIS score).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Patient with recently identified calcifications on mammography requiring biopsy. Patients will undergo a quantitative, multiparametric breast MRI as part of their clinical care. MRI will not change need for biopsy, but could identify additional suspicious sites. Only patients diagnosed with pure DCIS at biopsy and eventual surgical excision will receive Oncotype DX DCIS score testing. |
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| Cohort B | Patient with recent diagnosis of biopsy-proven DCIS would complete a research quantitative, multiparametric breast MRI as part of their clinical care. Only patients diagnosed with pure DCIS at surgical resection will receive Oncotype DX DCIS score testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast MRI | Diagnostic Test | Quantitative, multiparametric breast MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Fractional perfusion (f) | Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67) | 3.5 years |
| Tissue diffusion (Dt) | Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67) | 3.5 years |
| Transfer constant (Ktrans) | Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2) | 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Signal enhancement ratio (SER) | Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications | 3.5 years |
| Apparent diffusion coefficient (ADC) |
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Inclusion Criteria:
Exclusion Criteria for Both Cohorts:
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Women aged 18 or older with suspicious mammographic caclifications or biopsy-proven DCIS with residual calcifications present on mammogram after biopsy. Study participants will undergo an experimental 3 Tesla breast MRI prior to surgical resection, including both DWI and DCE techniques. Only participants who are diagnosed with pure DCIS on both core needle biopsy and surgical resection will remain on study. Tissue from all DCIS lesions will also be sent for outside multi-gene assay testing (Oncotype DX DCIS score, Genomic Health, Redwood City, CA).
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| Name | Affiliation | Role |
|---|---|---|
| Habib Rahbar | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Laboratory Biomarker Analysis |
| Other |
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing. |
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Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
| 3.5 years |
| Oncotype DCIS Score | Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score<39) | 3.5 years |
| Transfer constant (Ktrans) | Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha) | 3.5 years |
| Fractional perfusion (f) | Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF) | 3.5 years |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |