Breast Cancer, Stage 0
Conditions
Keywords
Ductal Carcinoma in Situ, MRI, Oncotype Dx
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).
Interventions
DIAGNOSTIC_TESTBreast MRI
Quantitative, multiparametric breast MRI
OTHERLaboratory Biomarker Analysis
Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
Sponsors
University of Washington
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Oncotype DCIS Score | 3.5 years | Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score\<39) |
| Transfer constant (Ktrans) | 3.5 years | Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha) |
| Fractional perfusion (f) | 3.5 years | Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHabib Rahbar
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed