This is a two staged clinical trial to investigate intraoperative fluorescence imaging in patientsundergoing TLE. WP-I is a dose finding study in which 2 doses will be tested with a possibility of a third dosing group. Every dosing cohort comprises 3 patients. After WP-I, an interim analysis will be performed to decide the optimal dose.~The optimal dose will be based on the TBR and the performance in detecting the most close margin (i.e. 'the sentinel margin'). A TBR of at least 1.5 is required for the optimal dose. If a positive margin is missed with fluorescence imaging, the concerned dose will be defined as suboptimal.~WP-II is an extension cohort of the optimal dose cohort selected in WP-I. WP-II will comprise of 18 patients.~The endpoints for WP-II are:~the rate of tumor free resection margins based on the current golden standard;~Sensitivity, specificity and positive predictive value of FLI;~The intraoperative change in surgical management based on FLI;~FLI of excised cervical lymph nodes;~Influence of previous radiotherapy on the FLI performance;~Adverse events and toxicity after intravenous injection with cRGD-ZW800-1;
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.