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Intraoperative Dual-modality Imaging in Renal Cell Carcinoma
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Carcinoma, Renal Cell | Drug: Indium-111-DOTA-Girentuximab-IRDye800CW Radiation: SPECT/CT Procedure: Intraoperative dual-modality imaging | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Diagnostic |
| 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 |
- 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 ]
| Estimated Enrollment: | 22 |
| Study Start Date: | June 2015 |
| Estimated Study Completion Date: | August 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Drug: Indium-111-DOTA-Girentuximab-IRDye800CW
Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy
Other Name: Dual-labeled girentuximab
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.
Other Name: Fluorescence and radioguided surgery
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT02497599
| Contact: Marlène Hekman, Drs. | 0031243619097 | marlene.hekman@radboudumc.nl |
| Netherlands | |
| Radboudumc | Recruiting |
| Nijmegen, Netherlands | |
| Contact: MCH Hekman, MD 0031243619097 marlene.hekman@radboudumc.nl | |
| Principal Investigator: | Peter FA Mulders, M.D. PhD | Radboud University |
| Study Director: | Wim JG Oyen, M.D. PhD | Radboud University |
More Information
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT02497599 History of Changes |
| Other Study ID Numbers: |
13071988 |
| Study First Received: | June 2, 2015 |
| Last Updated: | April 13, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Kidney Neoplasms Urologic Neoplasms |
Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 14, 2017