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

NCT ID: NCT04842162

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2026-11-30

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

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with head and neck cancer

Group Type: EXPERIMENTAL

indocyanine green

Intervention Type: DRUG

indocyanine green (INFRACYANINE© 25mg/10mL).

Interventions

indocyanine green

indocyanine green (INFRACYANINE© 25mg/10mL).

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Jules Bordet

Anderlecht, , Belgium

Site Status: RECRUITING

Gustave Roussy

Villejuif, Val De Marne, France

Site Status: RECRUITING

Countries

Belgium; France

Central Contacts

Philippe Gorphe, MD

Role: CONTACT

philippe.gorphe@gustaveroussy.fr

+33 (0)1 42 11 42 11

Facility Contacts

Antoine DIGONNET

Role: primary

Philippe Gorphe, MD

Role: primary

philippe.gorphe@gustaveroussy.fr

+33 (0)1 42 11 42 11

Thibaud Motreff

Role: backup

thibaud.motreff@gustaveroussy.fr

+33 (0)1 42 11 42 11

Other Identifiers

2019/2886

Identifier Type: OTHER

Identifier Source: secondary_id

2019-002442-20

Identifier Type: -

Identifier Source: org_study_id