Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC.

The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Clinical diagnosis of clear cell renal cell carcinoma planned for surgery, (partial) nephrectomy

• Performance status: Karnofsky 70 %

• Being fit for surgery

• Minimum age 18 years

• Signed informed consent

Exclusion Criteria:

• A known subtype other than clear cell RCC

• 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 and lactation