NCT03495011

MRI Characterization of Mammographically Detected DCIS

MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 122 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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).

Conditions

• Breast Cancer, Stage 0

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Breast MRI	Quantitative, multiparametric breast MRI
OTHER	Laboratory Biomarker Analysis	Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.

Timeline

• Start date: 2018-04-20
• Primary completion: 2023-04-30
• Completion: 2032-04-01
• First posted: 2018-04-11
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study