Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial (STELLAR)

Inclusion Criteria: Patients with biopsy-proven squamous cell Laryngeal and hypopharyngeal cancer, eligible for surgical resection of the tumor by TLE; ≥ 18 years of age; Written informed consent must be obtained; Sufficient knowledge of the Dutch language to understand the informed consent form; Exclusion Criteria: History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent; Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinoma of cervix and basal, squamous cell skin carcinoma, or other head- and neck squamous cell cancer; Patients pregnant or breastfeeding; Patients with renal insufficiency (defined as eGFR < 60); Patients with previous kidney transplantation or a solitary functioning kidney; Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors), that cannot be paused during the course of the study; Patients with ASA classification of 4 or higher; Patients with measured QTc of 500 ms or higher at screening; Patients with laboratory abnormalities defined as: Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or; Total bilirubin above 3 times the ULN or; Platelet count below 100 x 109/L or; Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males). Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired or weakened immune system, caused by either a preexisting disease or concomitant medications;