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NCT number NCT03495011
Study type Observational
Source University of Washington
Contact Habib Rahbar
Phone 206-606-6777
Email b-imaging-research@seattlecca.org
Status Recruiting
Phase
Start date April 2018
Completion date April 2032

Clinical Trial Summary

This is a single institution, prospective observational clinical trial for women with mammographically detected suspicious calcifications who have been recommended breast biopsy.

The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to biopsy can biologically characterize a common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.


Clinical Trial Description

The investigators will assess whether MRI signatures can determine which calcifications identified as suspicious on mammography 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 (TNF╬▒) 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 Design


Related Conditions & MeSH terms