MRI Characterization of Mammographically Detected DCIS

January 29, 2026 updated by: University of Washington

MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women aged 18 or older with suspicious mammographic caclifications or biopsy-proven DCIS with residual calcifications present on mammogram after biopsy. Study participants will undergo an experimental 3 Tesla breast MRI prior to surgical resection, including both DWI and DCE techniques. Only participants who are diagnosed with pure DCIS on both core needle biopsy and surgical resection will remain on study. Tissue from all DCIS lesions will also be sent for outside multi-gene assay testing (Oncotype DX DCIS score, Genomic Health, Redwood City, CA).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Oncotype Dx
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.
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.
Other Names:
  • Oncotype Dx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional perfusion (f)
Time Frame: 3.5 years
Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
3.5 years
Tissue diffusion (Dt)
Time Frame: 3.5 years
Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
3.5 years
Transfer constant (Ktrans)
Time Frame: 3.5 years
Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
3.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signal enhancement ratio (SER)
Time Frame: 3.5 years
Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
3.5 years
Apparent diffusion coefficient (ADC)
Time Frame: 3.5 years
Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
3.5 years
Oncotype DCIS Score
Time Frame: 3.5 years
Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score<39)
3.5 years
Transfer constant (Ktrans)
Time Frame: 3.5 years
Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)
3.5 years
Fractional perfusion (f)
Time Frame: 3.5 years
Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)
3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Habib Rahbar, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

April 30, 2023

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (Actual)

April 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9778
  • R01CA203883 (U.S. NIH Grant/Contract)
  • RG3017004 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • NCI-2021-12034 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer, Stage 0

Clinical Trials on Breast MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe