Breast Cancer, Stage 0 Clinical Trial
Official title:
MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ
Verified date | December 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05898789 -
Virtual Rehabilitation for Cancer Survivors
|
N/A |