Imaging Studies of Kidney Cancer Using 18F-VM4-037

Carcinoma, Renal Cell Clinical Trial

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

Status Terminated

Clinical Trial Summary

Background:

• 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.

Objectives:

• To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney cancer.

Eligibility:

• Adults at least 18 years of age with kidney cancer that will be treated with surgery.

Design:

• 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.

Clinical Trial Description

BACKGROUND:

• 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.

STUDY OBJECTIVES

PRIMARY OBJECTIVE:

• 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.

ELIGIBILITY:

• 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).

DESIGN:

• 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Neoplasms

• NCT number: NCT01712685
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Terminated
• Phase: Phase 2
• Start date: October 2012
• Completion date: August 2013