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Intraoperative Dual-modality Imaging in Renal Cell Carcinoma
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| First Received Date ICMJE | June 2, 2015 | ||||||
| Last Updated Date | April 13, 2017 | ||||||
| Start Date ICMJE | June 2015 | ||||||
| Estimated Primary Completion Date | July 2018 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | Complete list of historical versions of study NCT02497599 on ClinicalTrials.gov Archive Site | ||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Intraoperative Dual-modality Imaging in Renal Cell Carcinoma | ||||||
| Official Title ICMJE | 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 | ||||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase | Phase 1 | ||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Diagnostic |
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| Condition ICMJE | Carcinoma, Renal Cell | ||||||
| Intervention ICMJE |
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| Study Arms | 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.
Interventions:
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 22 | ||||||
| Estimated Completion Date | August 2018 | ||||||
| Estimated Primary Completion Date | July 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Netherlands | ||||||
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| Administrative Information | |||||||
| NCT Number ICMJE | NCT02497599 | ||||||
| Other Study ID Numbers ICMJE | 13071988 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement |
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| Responsible Party | Radboud University | ||||||
| Study Sponsor ICMJE | Radboud University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Radboud University | ||||||
| Verification Date | April 2017 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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