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Taking peoplePhase 2

Imaging dye tested to guide surgery for throat cancer

Tests a light-up dye to help surgeons see laryngeal and hypopharyngeal cancer during surgery.

Plain-language title generated from the registry record
Registry title: Fluorescence-guided Surgery in Laryngeal- and Hypopharyngeal Cancer: a Feasibility Trial

Key facts

Where
Rotterdam, NetherlandsSee the site
Phase
Phase 2

Where in Netherlands

  • Erasmus Medical CenterRotterdam, NetherlandsNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Erasmus Medical Center
Trial code
NCT05752149
Record updated
14 September 2026
Original 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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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; 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 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); Patients pregnant or breastfeeding; Patients with ASA classification of 4 or higher.

ClinicalTrials.gov NCT05752149