Clinical Trial · NCT02883153

Zirconium-89-girentuximab PET/CT Imaging in Renal Cell Carcinoma

Overview

Girentuximab is an antibody against Carbonic Anhydrase IX (CAIX), an antigen that is expressed on the cell surface of 95% of clear cell RCC (ccRCC). Zr-89-girentuximab PET/CT (Positron Emission Tomography) may be a valuable imaging technique in the diagnosis of patients with RCC. The aim of the present study is to show the impact of the Zr-89-girentuximab PET/CT on the clinical management of ccRCC patients.

Sponsor

Radboud University Medical Center

Phase

Phase 2/3

Contacts

Wim JG Oyen, MD (PRINCIPAL_INVESTIGATOR)

Peter FA Mulders, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02883153

Drug / Compound

girentuximab

Isotope(s):

Target(s):

CAIX

Ligand Class: Antibodies

Chelator: DFO

Eligibility

Inclusion

patients with a primary renal mass in whom it is unclear whether there is metastatic disease, or
patients with a renal mass of unknown origin, or
patients with a history of clear cell RCC with a suspicion of relapse or metastatic disease.
In order to participate in this study, a subject must meet all of the following criteria:
His or her clinician should face a diagnostic dilemma; e.g.

Exclusion

Any medical condition present that in the opinion of the investigator will affect patients' clinical status. - Administration of a radioisotope within 10 physical half lives prior to study enrollment
History of a CAIX-negative or non clear cell RCC.
Administration of tyrosine kinase inhibiters within 1 month prior to inclusion.
Pregnancy or lactation.
Known hypersensitivity or HACA (human anti chimeric antibodies) against Girentuximab.