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

Head and Neck Cancer Clinical Trial

— MAGNOLIA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04842162
• Other study ID #: 2019-002442-20
• Secondary ID: 2019/2886
• Status: Recruiting
• Phase: Phase 2
• Start date: December 15, 2020
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Philippe Gorphe, MD
• Phone: +33 (0)1 42 11 42 11
• Email: philippe.gorphe[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Anderlecht
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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