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

• Status: Completed
• Trial end date: 2017-06-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

In order to participate in this study, a subject must meet all of the following criteria:

1. His or her clinician should face a diagnostic dilemma; e.g.

• patients with a renal mass of unknown origin, or

• patients with a primary renal mass in whom it is unclear whether there is metastatic disease, or

• patients with a history of clear cell RCC with a suspicion of relapse or metastatic disease.

2. Minimum age 18 years

3. Signed informed consent

Exclusion Criteria:

• History of a CAIX-negative or non clear cell RCC.

• Administration of tyrosine kinase inhibiters within 1 month prior to inclusion.

• 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

• Pregnancy or lactation.

• Known hypersensitivity or HACA (human anti chimeric antibodies) against Girentuximab.