MRI Characterization of Mammographically Detected DCIS
- Conditions
- Breast Cancer, Stage 0
- Interventions
- Diagnostic Test: Breast MRIOther: Laboratory Biomarker Analysis
- Registration Number
- NCT03495011
- Lead Sponsor
- University of Washington
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 122
- [Cohort A] Women aged 18 or older with suspicious calcifications identified on mammography without an associated mass
- [Cohort B] Women aged 18 or older with recent biopsy-proven DCIS with residual calcifications present on mammogram after biopsy
Exclusion Criteria for Both Cohorts:
- Patients with prior history of breast cancer in the ipsilateral breast
- Patients with a newly diagnosed breast cancer in the contralateral breast
- Contra-indication to contrast-enhanced breast MRI (e.g. renal insufficiency with GFR<60, contrast allergy, incompatible metal)
- Patients who currently are undergoing chemoprevention therapy (e.g. aromatase inhibitors or selective estrogen receptor modulators)
- Women who are pregnant
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort B Laboratory Biomarker Analysis 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. Cohort A Breast MRI 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. Cohort A Laboratory Biomarker Analysis 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. Cohort B Breast MRI 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.
- Primary Outcome Measures
Name Time Method Fractional perfusion (f) 3.5 years Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
Tissue diffusion (Dt) 3.5 years Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
Transfer constant (Ktrans) 3.5 years Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
- Secondary Outcome Measures
Name Time Method Signal enhancement ratio (SER) 3.5 years Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
Transfer constant (Ktrans) 3.5 years Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)
Oncotype DCIS Score 3.5 years Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score\<39)
Fractional perfusion (f) 3.5 years Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)
Apparent diffusion coefficient (ADC) 3.5 years Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
Trial Locations
- Locations (1)
Fred Hutch/University of Washington Cancer Consortium
🇺🇸Seattle, Washington, United States