Imaging Correlates of Renal Cell Carcinoma Biological Features
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|ClinicalTrials.gov Identifier: NCT01665703|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2012
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Procedure: FDG PET/MR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LCCC 1213: Defining Molecular and Functional Imaging Correlates of Renal Cell Carcinoma Biological Features|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||August 2019|
Experimental: FDG PET/MR
Participents will undergo a gadolinium enhanced FDG PET/MR study.
Procedure: FDG PET/MR
Patients will be asked to undergo a voluntary gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake within 4 weeks prior to surgery.
Other Name: Fluorodeoxyglucose Positron Emission Tomography MRI
- Feasibility of FDG-PET-MRI making useful measurements that might be then used to globally assess tumor biological features [ Time Frame: 4 weeks ]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.
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): NCT01665703
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Weili Lin, PhD||University of North Carolina|