Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

Radboud University Medical Center

Status and phase: Unknown; Phase 1

Conditions: Carcinoma, Renal Cell

Treatments: Radiation: SPECT/CT; Procedure: Intraoperative dual-modality imaging; Drug: Indium-111-DOTA-Girentuximab-IRDye800CW

Study type: Interventional

Funder types: Other

Identifiers

NCT02497599

13071988

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Intraoperative dual-modality imaging

Experimental group

Description:

Patients receive a single intravenous dose of Indium-111-DOTA-Girentuximab-IRDye800CW. At day 4 or 5 after antibody injection a whole body planar scan and SPECT/CT scan will be acquired. At day 7 standard of care (partial) nephrectomy will be performed. This will be extended with the use of dual-modality imaging.

Treatment:

Drug: Indium-111-DOTA-Girentuximab-IRDye800CW

Procedure: Intraoperative dual-modality imaging

Radiation: SPECT/CT