Fluorescence-guided surgery to help remove laryngeal and hypopharyngeal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-stage, open-label study evaluating a fluorescent imaging agent (cRGD-ZW800-1) given by IV dose during total laryngectomy. In the first stage, three-patient dose cohorts test two doses (with a possible third) to find the dose that best highlights tumor margins, aiming for a tumor-to-background ratio of at least 1.5. In the second stage, the selected optimal dose is given to 18 patients to see if fluorescence imaging improves detection of tumor-free margins and influences intraoperative decisions. Outcomes include margin status, diagnostic performance of fluorescence imaging, changes in surgical management, imaging of cervical lymph nodes, and safety. The study is conducted at Erasmus Medical Center in the Netherlands and involves adults with biopsy-proven squamous cell cancer of the larynx or hypopharynx.

Why it matters

Who can join: the full rules

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;

Where it's running

• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting
• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.