NCT04842162RecruitingPhase 2
Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 8 Apr 2021
- Start date
- 15 Dec 2020
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Diseases
- Head and neck cancer
- NCT number
- NCT04842162
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 65
- From 15 Dec 2020 to the primary completion date, 30 Nov 2026
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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
Lab values
- Advanced renal failure (creatinine \> 1.5mg/dL).
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.