TheranosticTrials.org

Clinical Trial · NCT03556046

89Zr-girentuximab ) Dosimetry in CCRC Study - ZIR-DOSE

Overview

The study is designed to explore the safety and tolerability as well as diagnostic 89Zr-girentuximab for imaging CCRC by PET/CT. This study does not offer any treatment for patients with CCRC; therefore, patients will be offered state of the art therapeutic options after imaging with the study drug 89Zr-girentuximab. Cancer treatment will not be delayed by study participation.

Sponsor

Radboud University Medical Center

Phase

Phase 1

Contacts

Michael Tapner (STUDY_DIRECTOR)

Peter F. A. Mulders, Prof. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03556046

Drug / Compound

girentuximab

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies

girentuximab

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • 1. Written informed consent
  • Male or female \>50 years of age
  • Consent to practise double-barrier contraception until end of study (7 days after 89Zr-girentuximab injection)
  • Life expectancy of at least 6 months
  • Clinical suspicion of CCRC, based on imaging evidence of a renal mass, requiring further diagnostic work-up or patients with established diagnosis of CCRC requiring imaging for recurrent disease

Exclusion

  • 1. Known hypersensitivity to girentuximab
  • Exposure to any radiopharmaceutical within 30 days (corresponding to 8 half-lives of 89Zr) prior to the administration of 89Zr-girentuximab.
  • Ongoing toxicity grade 2 from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.03)
  • Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-girentuximab
  • Known uncontrolled hyperthyreoidism