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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03495011
Other study ID # 9778
Secondary ID R01CA203883RG301
Status Active, not recruiting
Phase
First received
Last updated
Start date April 20, 2018
Est. completion date April 2032

Study information

Verified date December 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 122
Est. completion date April 2032
Est. primary completion date April 30, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Washington National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional perfusion (f) Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67) 3.5 years
Primary Tissue diffusion (Dt) Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67) 3.5 years
Primary Transfer constant (Ktrans) Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2) 3.5 years
Secondary Signal enhancement ratio (SER) Assess whether low SER can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications 3.5 years
Secondary Apparent diffusion coefficient (ADC) Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications 3.5 years
Secondary Oncotype DCIS Score Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score<39) 3.5 years
Secondary Transfer constant (Ktrans) Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha) 3.5 years
Secondary Fractional perfusion (f) Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF) 3.5 years
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