drugset / Trial / NCT05752149
Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
Non-randomizedSequentialSingle-blindDiagnostic
Summary
This is an open-label, single-dose, prospective clinical trial. The study comprises 2 work packages. The main objective of work package I (WP-1) is to assess feasibility of Fluorescence imaing (FLI) during total laryngectomy (TLE) and to assess the optimal dose of the cRGD-ZW800-1. Work package II (WP-II) is designed to assess whether FLI can detect and decrease tumor positive margins after a TLE.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2027-02-01
- Completion
- 2027-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cRGD-ZW800-1 | Diagnostic / imaging agent | 0.01 mg/kg | Intravenous |
| Subject | cRGD-ZW800-1 | Diagnostic / imaging agent | 0.025 mg/kg | Intravenous |
| Subject | cRGD-ZW800-1 | Diagnostic / imaging agent | 0.05 mg/kg | Intravenous |