MRI Characterization of Mammographically Detected DCIS

N/AActive Not RecruitingNCT03495011

University of Washington122 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Breast Cancer, Stage 0

Interventions

Breast MRIDIAGNOSTIC_TEST

Quantitative, multiparametric breast MRI

Laboratory Biomarker AnalysisOTHER

Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

Fractional perfusion (f)

Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)

Time frame: 3.5 years

Tissue diffusion (Dt)

Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)

Time frame: 3.5 years

Transfer constant (Ktrans)

Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)

Time frame: 3.5 years

Secondary Outcomes

Signal enhancement ratio (SER)

Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications

Time frame: 3.5 years

Apparent diffusion coefficient (ADC)

Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications

Time frame: 3.5 years

Oncotype DCIS Score

Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score\<39)

Time frame: 3.5 years

Transfer constant (Ktrans)

Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)

Time frame: 3.5 years

Fractional perfusion (f)

Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)

Data from ClinicalTrials.gov

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