Clinical trial NCT04842162: Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Official title: Study Evaluating Near-infrared Imaging Coupled With Indocyanine Green for Intraoperative Control of Resection Margins in ENT Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non-randomized bicentric study
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Sensitivity of Near Infrared Fluorescence Imaging
timeFrame: at surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References: