Clinical trial · Interventional
Intraoperative Dual-modality Imaging in Renal Cell Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indium-111-DOTA-Girentuximab-IRDye800CW | Drug | — | UNRESOLVED |
| Intraoperative dual-modality imaging | Procedure | — | UNRESOLVED |
| SPECT/CT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative dual-modality imaging
- 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.
- interventionNames
- Drug: Indium-111-DOTA-Girentuximab-IRDye800CW
- Radiation: SPECT/CT
- Procedure: Intraoperative dual-modality imaging
Primary outcomes (1)
- measure
- Fluorescent signal at time of surgery
- timeFrame
- During surgery
- description
- Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available