MRI Characterization of Mammographically Detected DCIS

NCT03495011 | Active Not Recruiting FDA Device

• 4 other identifiers: 9778R01CA203883RG3017004NCI-2021-12034
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer, Stage 0

Keywords

Ductal Carcinoma in Situ; MRI; Oncotype Dx

Outcome Measures

Primary Outcomes (3)

• Fractional perfusion (f)

  Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)

  3.5 years

• Tissue diffusion (Dt)

  Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)

  3.5 years

• Transfer constant (Ktrans)

  Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)

  3.5 years

Secondary Outcomes (5)

• Signal enhancement ratio (SER)

  3.5 years

• Apparent diffusion coefficient (ADC)

  3.5 years

• Oncotype DCIS Score

  3.5 years

• Transfer constant (Ktrans)

  3.5 years

• Fractional perfusion (f)

  3.5 years

Study Arms (2)

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; Other: Laboratory Biomarker Analysis

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; Other: Laboratory Biomarker Analysis

Interventions

Breast MRI DIAGNOSTIC_TEST

Quantitative, multiparametric breast MRI

Cohort A; Cohort B

Laboratory Biomarker Analysis OTHER

Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.

Also known as: Oncotype Dx

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \[Cohort A\] 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Habib Rahbar

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: April 20, 2018
• Primary Completion: April 30, 2023
• Study Completion (Estimated): April 1, 2032
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)