Clinical trial NCT03495011: MRI Characterization of Mammographically Detected DCIS
Official title: MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer, Stage 0
Keywords: Ductal Carcinoma in Situ
MRI
Oncotype Dx
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2018-04-11
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Fractional perfusion (f)
timeFrame: 3.5 years
measure: Tissue diffusion (Dt)
timeFrame: 3.5 years
measure: Transfer constant (Ktrans)
timeFrame: 3.5 years
Secondary outcomes:
measure: Signal enhancement ratio (SER)
timeFrame: 3.5 years
measure: Apparent diffusion coefficient (ADC)
timeFrame: 3.5 years
measure: Oncotype DCIS Score
timeFrame: 3.5 years
measure: Transfer constant (Ktrans)
timeFrame: 3.5 years
measure: Fractional perfusion (f)
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Habib Rahbar
role: PRINCIPAL_INVESTIGATOR
References: