Tests a dye imaging method to check surgical edges in head and neck cancer
Tests a dye-based imaging method during surgery for head and neck cancer in adults.
Plain-language title generated from the registry record
Registry title: Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Key facts
- Where
- Anderlecht, BelgiumSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with squamous cell carcinoma of the mouth or the middle part of the throat (oropharynx) whose tumour can be fully removed by surgery.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Squamous cell carcinoma confirmed by tissue examination, in the oral cavity or oropharynx. The disease must be operable for complete removal.
- Earlier treatment
- People with a history of radiation for head and neck cancer cannot join.
Main reasons for not taking part
- Pregnant or nursing women
- Metastatic cancer
- History of head and neck cancer in the past 5 years
- History of radiation for head and neck cancer
- Allergy to the study product, iodized products or crustaceans
Read by machine on 12 November 2026.
Where in Belgium
- Institut Jules BordetAnderlecht, BelgiumContact: Antoine DIGONNETTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Gustave Roussy, Cancer Campus, Grand Paris
- Trial code
- NCT04842162
- Record updated
- 26 November 2025
- Original description
Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancersRead full original descriptionShow less
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Assess the sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after a complete macroscopic surgical resection of head and neck cancers
Inclusion: 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: Severe medical co-morbidities or contraindications to surgery; Within 2 weeks prior to inclusion, concomitant medication that reduces or increases extinction of GI (i.e. anticonvulsants, haloperidol and Heparin); History of head and neck cancer in the past 5 years; History of radiation for head and neck cancer; Metastatic cancer; History of invasive cancer unless there has been no recurrence for more than 5 years with an exception for non-melanoma skin cancers; 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); Primary tumour not operable; Tumours with necrosis ranges in pre-operative imaging; Pregnant or nursing woman; 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.