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

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasmus Medical Center

Criteria

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;