Imaging Studies of Kidney Cancer Using 18F-VM4-037
- The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans. Researchers want to see how well it works for scans for people who have kidney cancer.
- To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney cancer.
- Adults at least 18 years of age with kidney cancer that will be treated with surgery.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have two positron emission tomography (PET) scans of their kidneys. They will have the scans before and after receiving an injection of 18F-VM4-037. The scans will take about 2 hours to complete.
- About 3 weeks after the PET scans, participants will provide tumor tissue samples from their kidneys.
- This is a scanning study only. Treatment will not be provided as part of this study.
Carcinoma, Renal Cell
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||PET Imaging Of Renal Cell Carcinoma With 18F-VM4-037: A Phase II Pilot Study For Detection Of Disease And Correlation With VHL Mutation Status|
- Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs) [ Time Frame: 58 days ] [ Designated as safety issue: No ]The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both "non-tumor" tissue.
- Number of Participants With Adverse Events [ Time Frame: 58 days ] [ Designated as safety issue: Yes ]Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
|Study Start Date:||October 2012|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
|Experimental: Renal Cell Carcinoma||
Drug being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans.Procedure: PET/CT
- Carbonic Anhydrase IX (CA IX) is a hypoxia-inducible enzyme regulated by the Von Hippel Lindau (VHL) protein that is commonly overexpressed in certain malignancies including renal cell carcinoma (RCC) and may have prognostic significance.
- The VHL gene is commonly mutated or inactivated in RCC tumors and VHL activity regulated the expression and activity of not only CAIX but also CAXII as well as other genes critical for tumor angiogenesis such as vascular endothelial growth factor (VEGF), glucose transporter 1 (GLUT1), glucose transporter 3 (GLUT 3) and platelet derived growth factor (PDGF).
- 18F-VM4-037 is an imaging drug product formulation which binds to the active site ligand of CA-IX and also binds to CAXII. We propose to evaluate 18F-VM4-037 as a positron emission imaging (PET) radiopharmaceutical for the in vivo detection of CA-IX and CAXII in renal tumors.
- To evaluate the biodistribution of 18F-VM4-037 within tumor and non-tumor tissues.
- To assess safety of 18F-VM4-037 in patients with primary or metastatic RCC.
- Subject is greater than or equal to 18 years old, Eastern Cooperative Oncology Group (ECOG) 0-2.
- Subject must have confirmed primary RCC (greater than or equal to 2.5cm) in diameter on conventional imaging modality or extrarenal/extrahepatic RCC lesion (greater than or equal to 1cm).
- Twenty subjects with primary RCC greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic lesion suspicious for metastatic RCC (greater than or equal to 1cm in diameter) scheduled for clinically indicated surgery or biopsy will undergo dynamic 18F-VM4-037 PET/CT imaging. Results will be compared with pathology.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712685
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Adam R Metwalli, M.D.||National Cancer Institute (NCI)|