Etude évaluant l’imagerie proche infrarouge couplée au vert d’indocyanine pour le contrôle peropératoire des marges de résection en chirurgie ORL (MAGNOLIA)

Phase 1

Recruiting

Conditions: epidermoid carcinoma
MedDRA version: 21.1Level: PTClassification code: 10067821Term: Head and neck cancer Class: 100000004864
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: CTIS2022-502737-26-00

Lead Sponsor: Institut Gustave Roussy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 65

Inclusion Criteria

Male or female, 18 years of age or older - ECOG performance status 0-2 - Histological confirmation of epidermoid carcinoma - Location of the primary tumor in the oral cavity or oropharynx - Operable disease with the intention of complete resection - Negative serum or urine pregnancy test (depending on the center's practice) within 14 days prior to systemic injection of indocyanine green (pre-operative visit), for women of childbearing potential - informed consent form signed by the patient - Patient affiliated with a social security plan or beneficiary of a similar plan. - Patient must understand, sign and date the informed consent form prior to any protocol specific procedure. Patient must be able and willing to comply with study visits and procedures outlined in the protocol.

Exclusion Criteria

Severe medical co-morbidities or contraindications to surgery - Non-operable primary tumor - History of head and neck cancer in the last 5 years - History of radiation treatment for head and neck cancer - Metastatic cancer - Tumors with necrotic areas on preoperative 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 breastfeeding woman - Allergy or hypersensitivity to the administered product (its active substance or other ingredients), to iodized products or to shellfish. - 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 ICG extinction (i.e. anticonvulsants, haloperidol and Heparin). - Patients under guardianship or deprived of liberty by judicial or administrative decision or patients unable to give consent. - Patients unable to comply with the medical follow-up of the trial