MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
Overview
- Phase
- Not Applicable
- Intervention
- Breast MRI
- Conditions
- Breast Cancer, Stage 0
- Sponsor
- University of Washington
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Fractional perfusion (f)
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •\[Cohort A\] 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
Arms & Interventions
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.
Intervention: Breast MRI
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.
Intervention: Laboratory Biomarker Analysis
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.
Intervention: Breast MRI
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.
Intervention: Laboratory Biomarker Analysis
Outcomes
Primary Outcomes
Fractional perfusion (f)
Time Frame: 3.5 years
Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
Tissue diffusion (Dt)
Time Frame: 3.5 years
Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
Transfer constant (Ktrans)
Time Frame: 3.5 years
Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
Secondary Outcomes
- Signal enhancement ratio (SER)(3.5 years)
- Transfer constant (Ktrans)(3.5 years)
- Oncotype DCIS Score(3.5 years)
- Fractional perfusion (f)(3.5 years)
- Apparent diffusion coefficient (ADC)(3.5 years)