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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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 neck cancer

• Metastatic cancer

• Tumours with necrosis ranges in pre-operative 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 nursing woman

• 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).

• Within 2 weeks prior to inclusion, concomitant medication that reduces or increases extinction of GI (i.e. anticonvulsants, haloperidol and Heparin).

• 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