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

Gustave Roussy

Status and phase

Enrolling

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: indocyanine green

Study type

Interventional

Funder types

Other

Identifiers

NCT04842162

2019/2886 (Other Identifier)

2019-002442-20

Details and patient eligibility

About

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

Enrollment

65 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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