MRI Characterization of Mammographically Detected DCIS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03495011|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : May 15, 2019
This is a single institution, prospective observational clinical trial for women with mammographically detected suspicious calcifications who have been recommended breast biopsy.
The purpose of this study is to determine whether quantitative, multiparametric breast MRI performed prior to biopsy can biologically characterize a common pre-invasive malignancy, ductal carcinoma in situ (DCIS), which typically presents in asymptomatic women as suspicious calcifications on mammography.
|Condition or disease||Intervention/treatment|
|Breast Cancer, Stage 0||Diagnostic Test: Breast MRI Other: Laboratory Biomarker Analysis|
The investigators will assess whether MRI signatures can determine which calcifications identified as suspicious on mammography 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).
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||MRI Characterization of Mammographically Detected Calcifications and Ductal Carcinoma in Situ|
|Actual Study Start Date :||April 20, 2018|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2032|
Patient with suspicious calcifications identified on mammogram would complete a research quantitative, multiparametric breast MRI prior to core needle biopsy. Patients diagnosed with pure DCIS on breast biopsy and subsequent surgical resection will receive Oncotype DX DCIS score testing.
Diagnostic Test: Breast MRI
Breast MRI prior to clinical breast biopsy
Other: Laboratory Biomarker Analysis
Oncotype Dx testing will be done on surgical specimen of pure DCIS
Other Name: Oncotype Dx
- Fractional perfusion (f) [ Time Frame: 3.5 years ]Assess whether high f within DCIS lesions correlates with proliferation (high Ki-67)
- Tissue diffusion (Dt) [ Time Frame: 3.5 years ]Assess whether low Dt within DCIS lesions correlates with high proliferation (Ki-67)
- Transfer constant (Ktrans) [ Time Frame: 3.5 years ]Assess whether high Ktrans within DCIS lesions correlates with inflammation (cox-2)
- Signal enhancement ratio (SER) [ Time Frame: 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) [ Time Frame: 3.5 years ]Assess whether high ADC can exclude the presence of DCIS-associated malignancy at the site of mammographic calcifications
- Oncotype DCIS Score [ Time Frame: 3.5 years ]Develop a multivariate MRI model to identify low risk DCIS (Oncotype DX DCIS score<39)
- Transfer constant (Ktrans) [ Time Frame: 3.5 years ]Assess whether high Ktrans in the peri-tumoral tissue correlates with stromal inflammation (TNFalpha)
- Fractional perfusion (f) [ Time Frame: 3.5 years ]Assess whether high f in the peri-tumoral tissue correlates with angiogenesis (VEGF)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495011
|Contact: Habib Rahbaremail@example.com|
|Contact: Research Coordinator||206-606-6714|
|United States, Washington|
|Seattle Cancer Care Alliance||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Research Coordinator 206-606-6714|