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Glow-in-the-Dark dye could help surgeons see hidden cancer cells

NCT ID NCT04842162

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a special dye (indocyanine green) and a near-infrared camera can help surgeons see tiny bits of cancer left behind during head and neck cancer surgery. About 65 adults with oral or throat cancer will receive the dye before surgery. The camera will scan the surgical area, and results will be compared with standard lab tests to see how accurate the imaging is at finding leftover disease.

What this could mean

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

Active substance
indocyanine green (a dye injected into the bloodstream)
What this could lead to
If successful, this imaging technique could help surgeons remove all cancer cells during surgery, potentially reducing the need for additional treatments.
What could go wrong
This is a small, early-phase study (65 people) focused on accuracy, not on long-term outcomes. The dye may not reliably detect all microscopic disease, and results may not apply to all head and neck cancers.

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 65 people

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

Started

Dec 2020

Expected to finish

Nov 2026

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: * Male or female 18 years of age or older * ECOG performance status 0-2 * Histological confirmation of squamous cell carcinoma * Locating the primary tumour in the oral cavity or oropharynx * Disease operable for complete resection * Serum or urinary pregnancy test (as per centre practices) negative within 14 days prior to systemic indocyanin green injection (pre-operative visit), for women of childbearing age * Patient information and signed free and informed consent * Patient affiliated with a social security scheme or beneficiary of a similar scheme. * The patient must understand, sign and date the consent form prior to any protocol-specific procedures. The patient must be able and willing to comply with the study visits and procedures described in the protocol Exclusion Criteria: * Severe medical co-morbidities or contraindications to surgery * Primary tumour not operable * History of head and neck cancer in the past 5 years * History of radiation for head and neck cancer * Metastatic cancer * Tumours with necrosis ranges in pre-operative imaging * History of invasive cancer unless there has been no recurrence for more than 5 years with an exception for non-melanoma skin cancers. * Pregnant or nursing woman * Allergy or hypersensitivity to the product being administered (its active substance or other ingredients), iodized products or crustaceans. * Hyperthyroidism, thyroid adenoma, unifocal, multifocal or multinodular goiter of autoimmune origin. * Documented coronary artery disease * Advanced renal failure (creatinine \> 1.5mg/dL). * Within 2 weeks prior to inclusion, concomitant medication that reduces or increases extinction of GI (i.e. anticonvulsants, haloperidol and Heparin). * Patient under guardianship or curatorship or deprived of liberty by judicial or administrative decision or patient unable to give consent. * Patients unable to undergo medical follow-up of the trial

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms

As listed by the trial registrant

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

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 in 2 countries. 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

  • Gustave Roussy

    RECRUITING

    Villejuif, Val De Marne, 94800, France

  • Institut Jules Bordet

    RECRUITING

    Anderlecht, 1070, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.