← Back to Clinical Trials
Recruiting Phase 2 NCT04842162

Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery

Trial Parameters

Condition Head and Neck Cancer
Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 65
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-12-15
Completion 2026-11
Interventions
indocyanine green

Brief Summary

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

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 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 n

Related Trials