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

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.

Eligibility

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;

Conditions3

Interventions1

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