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

Prior treatment

• 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;
• 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;

Other illness

• 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;

Lab values

• Patients with renal insufficiency (defined as eGFR \< 60);
• 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).

Other

• Patients pregnant or breastfeeding;
• Patients with ASA classification of 4 or higher;

• 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;