MRI Characterization of Mammographically Detected DCIS

Active, not recruiting

• Conditions: Breast Cancer, Stage 0

• Registration Number: NCT03495011
• Lead Sponsor: University of Washington

Brief 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).

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-11
• Study Start: 2018-04-20
• Primary Completion: 2023-04-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Study Completion: 2032-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 122

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States