Squamous Cell Carcinoma of the Larynx Clinical Trial
Official title:
The STELLAR Trial: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial
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.
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; ;
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