Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

Carcinoma, Renal Cell Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Safety and Feasibility of Intraoperative Detection of Clear Cell Renal Cell Carcinoma Using Indium-111-DOTA-girentuximab-IRDye800CW

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02497599
• Other study ID #: 13071988
• Status: Recruiting
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: April 2022

Study information

• Verified date: March 2021
• Source: Radboud University
• Contact: Robin Merkx, Drs.
• Phone: 0031243666283
• Email: Robin.Merkx[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. Intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen. 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 concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.

Eligible patients with renal cell carcinoma scheduled for (partial) nephrectomy will receive dual-labeled girentuximab 7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen will be obtained. Surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• Indium-111-DOTA-Girentuximab-IRDye800CW
Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy

Radiation:
• SPECT/CT
4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired.

Procedure:
• Intraoperative dual-modality imaging
7 days after dual-labeled girentuximab injection standard of care surgery will be performed extended with the use of dual-modality imaging.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescent signal at time of surgery	Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No	During surgery
Secondary	Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0	The number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 will be scored.	4 weeks
Secondary	Blood levels of the dual-labeled antibody	Blood samples will be measured for radioactivity in a gamma counter at different timepoints after injection. This will be expressed as percentage injected dose per gram (%ID/g).	60, 120 and 180 minutes after injection and 4 and 7 days after injection
Secondary	Optimal dose of the dual-labeled antibody preparation	Tumor to background ratio will be evaluated for each dose.	4 weeks