MRI Characterization of Mammographically Detected DCIS

Breast Cancer, Stage 0 Clinical Trial

Official title:

MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03495011
• Other study ID #: 9778
• Secondary ID: R01CA203883RG301
• Status: Active, not recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer, Stage 0
• Breast Carcinoma In Situ
• Carcinoma in Situ

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