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MRI Characterization of Mammographically Detected DCIS

NCT03495011 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

  • Breast Cancer, Stage 0

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Habib Rahbar · Fred Hutch/University of Washington Cancer Consortium

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-20
Primary Completion
2023-04-30
Completion
2032-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03495011 on ClinicalTrials.gov