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

NCT04842162 | Recruiting Phase 2

• 2 other identifiers: 2019-002442-202019/2886
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Near Infrared Fluorescence Imaging

  Sensitivity of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the operating room after complete macroscopic surgical resection. For the calculation of the sensitivity, for each operating room we consider the first section and the last section in which the pathological analysis confirms the presence of microscopic residual disease. Patients for whom near-infrared fluorescence imaging detects disease are classified as true positives (TP). Sensitivity is defined as the number of TP divided by the total number of patients N.

  at surgery

Study Arms (1)

Patients with head and neck cancer

EXPERIMENTAL

Drug: indocyanine green

Interventions

indocyanine green DRUG

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

Patients with head and neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (2)

Institut Jules Bordet

Anderlecht, 1070, Belgium

RECRUITING

Gustave Roussy

Villejuif, Val De Marne, 94800, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Philippe Gorphe, MD

CONTACT

+33 (0)1 42 11 42 11; philippe.gorphe@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective non-randomized bicentric study

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: December 15, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

BE (1); FR (1)