Glow-in-the-Dark dye could help surgeons see hidden cancer cells
NCT ID NCT04842162
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Gustave Roussy
RECRUITINGVillejuif, Val De Marne, 94800, France
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Institut Jules Bordet
RECRUITINGAnderlecht, 1070, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer
- Can an online program ease the burden on cancer caregivers?