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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Erasmus Medical Center • ClinicalTrials.gov ID: NCT05752149

Registry updated: 2026-09-14
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Description

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.

Interventions

  • CRGD-ZW800-1 (Drug)
    Intravenous administration of study drug at lesat 2h prior to surgery

Eligibility 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;

Conditions

Squamous Cell Carcinoma of the Larynx Squamous Cell Carcinoma of the Hypopharynx

Locations

  • Erasmus Medical Center — Rotterdam, South Holland, Netherlands
  • Erasmus Medical Center — Rotterdam, South Holland, Netherlands
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record