Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Recruiting
Phase 2
Interventional Study
Head and Neck Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 65 (estimated)
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris · Other
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About This Trial
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
Trial Locations
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Eligibility Criteria
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 centr…
Contacts