LCCC 1213: Defining Molecular and Functional Imaging Correlates of Renal Cell Carcinoma Biological Features
This pilot study is designed to evaluate imaging parameters indicative of underlying tumor
biology. Patients with large renal masses (>3 cm, or at the discretion of the investigator)
who are planning to undergo nephrectomy will be identified, and recruited to undergo a
contrast-enhanced magnetic resonance-Fluorodeoxyglucose-positron emission tomography
(MR-FDG-PET) scan. Samples collected from their tumor after it is removed will undergo a
variety of laboratory tests, including biomarker assessments and genotyping. By examining
primary renal masses via a combination of MR and FDG-PET functional imaging in concert with
tissue based tests, areas of hypermetabolism and hypervascularization will be evaluated as
features of HIF activation or tumor subtype.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features
This is a feasibility study. Feasibility will be determined by the quality of the FDG-PET-MRI measurements. That is, the measurements represent what the investigators hope they are measuring. With 10 of 10, the 100% rate has an exact 95% confidence interval of 69% to 100%. The interval width, representing a measure of precision, is 31%. The tumor biological features that will be assessed include genetic analyses performed for commonly mutated genes in kidney cancer (VHL, PBRM1, SETD2, HIF1, UTX, MLL2) and protein expression analyses performed on HIF1 and HIF2 protein expression using standard immunohistochemistry. These genetic and protein expression analyses will be performed on tissue samples collected within four weeks of imaging from tissue removed via nephrectomy.
4 weeks
No
Kimryn Rathmell, MD
Principal Investigator
University of North Carolina
United States: Institutional Review Board
LCCC 1213
NCT01665703
August 2012
August 2019
Name | Location |
---|---|
Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599-7305 |