Intraoperative Dual-modality Imaging in Renal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02497599|
Recruitment Status : Active, not recruiting
First Posted : July 14, 2015
Last Update Posted : September 4, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Renal Cell||Drug: Indium-111-DOTA-Girentuximab-IRDye800CW Radiation: SPECT/CT Procedure: Intraoperative dual-modality imaging||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Intraoperative dual-modality imaging
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.
Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy
Other Name: Dual-labeled girentuximab
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.
Other Name: Fluorescence and radioguided surgery
- Fluorescent signal at time of surgery [ Time Frame: During surgery ]Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No
- 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 [ Time Frame: 4 weeks ]The number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 will be scored.
- Blood levels of the dual-labeled antibody [ Time Frame: 60, 120 and 180 minutes after injection and 4 and 7 days after injection ]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).
- Optimal dose of the dual-labeled antibody preparation [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497599
|Principal Investigator:||Peter FA Mulders, M.D. PhD||Radboud University|
|Study Director:||Wim JG Oyen, M.D. PhD||Radboud University|