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Glowing dye lights up throat tumors during surgery

NCT ID NCT05752149

Diagnosis Sponsor: Erasmus Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether a fluorescent dye called cRGD-ZW800-1 can help surgeons see laryngeal and hypopharyngeal tumors more clearly during total laryngectomy. The trial has two parts: first, to find the best dose of the dye by measuring how brightly it lights up tumor tissue compared to normal tissue; second, to see if using the dye helps surgeons remove the cancer with clear margins. The study enrolls 27 adults with biopsy-proven squamous cell cancer of the larynx or hypopharynx who are scheduled for surgery. Participants receive a single intravenous dose of the dye at least two hours before surgery, and surgeons use a special camera to detect the fluorescence.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cRGD-ZW800-1, an experimental fluorescent imaging agent given intravenously before surgery
What this could lead to
If it works, surgeons could use this dye to see tumor edges more clearly and remove throat cancers more completely, possibly lowering the chance that cancer cells are left behind.
What could go wrong
This is a small, early-phase feasibility trial with 27 participants, so it may not show a clear benefit or may not work for all patients. The dye could cause allergic reactions, and finding a good dose does not guarantee better surgical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

hypopharynx squamous cell carcinoma laryngeal squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous cell carcinoma of the hypopharynx Squamous cell carcinoma of the larynx

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Erasmus Medical Center

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015GD, Netherlands

  • Erasmus Medical Center

    RECRUITING

    Rotterdam, South Holland, 3015GD, Netherlands

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