visualization of the resection margins by near infrared fluorescence imaging (in vivo and ex vivo) for patients over 18 years of age with ENT epidermoid cancer treated by open surgery or by robot-assisted transoral approach MedDRA version: 21.1 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Infracyanine
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: INDOCYANINE GREEN
CAS Number: 3599-32-4
Other descriptive name: INDOCYANINE GREEN
Conce
Sponsors
Gustave Roussy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Man or Woman with an age >= 18 years, - ECOG performance status 0-2, - Histological confirmation of squamous cell carcinoma, - Localization of primary tumor in the oral cavity or the oropharynx, - Operable disease with intent to be complete resection, - Medical or urinary pregnancy test (negative) in the 14 days preceding the systemic injection of indocyanine green (preoperative visit), for women of childbearing age, -Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol., - Patient affiliated to a social security regimen or beneficiary of the same according to local requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: - Severe medical co-morbidities or contraindications to surgery, - Nonoperable primary tumor, - History of head and neck cancer in the last 5 years, - Radiation history for head and neck cancer, - Metastatic cancer, - Neoplasms with plaques of necrosis in preoperative imaging, - History of invasive cancer except if no recurrence for more than 5 years with an exception for non-melanoma skin cancers, - Pregnant or lactating woman, - Allergy or hypersensitivity to the administered product (its active substance or other ingredients), iodized products or crustaceans, - Hyperthyroidism, thyroid adenoma, unifocal, multifocal or multinodular goitre of autoimmune origin, - Documented coronary artery disease, - Advanced renal insufficiency (creatinine> 1.5mg / dl), - In the 2 weeks prior to inclusion, concomitant medication that reduces or increases the extinction of ICG (ie anticonvulsants, haloperidol and Heparin), - Patient under tutorship or curatorship or deprived of liberty by a judicial or administrative decision or patient unable to give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the sensitivity of near-infrared fluorescence imaging in real time to detect microscopic residual disease in the surgical specimen after complete macroscopic surgical resection of head and neck cancers;Secondary Objective: -evaluate the specificity of intraoperative near-infrared fluorescence imaging, i.e. its ability to discriminate healthy margins of head and neck cancers. -to evaluate the positive predictive value of the intraoperative nearinfrared fluorescence imaging on the operating bed, during a new surgical resection after extemporaneous examination of the suspect zones. - Analyze the mapping and kinetics of the tumor-to-background ratio (TBR) for head and neck cancers. - to evaluate the incidence and grades of significant adverse effects due to the injection of ICG (indocyanine green) as a measure of the safety and tolerability of the method. - to determine the value of near infrared fluorescence imaging combined with ICG for robotic transoral surgery using the Intuitive Firefly module compared to ICG-associated NIRF imaging in the case of open surgery: sensitivity, specificity, mapping and kinetics of the tumor / background ratio.;Primary end point(s): Sensitivity of real-time near-infrared fluorescence imaging in the first and last sections in which the pathological examination confirms the presence of microscopic residual disease after complete macroscopic surgical resection;Timepoint(s) of evaluation of this end point: J1 - Real-time evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Specificity of real-time near-infrared fluorescence imaging to detect healthy margins in real time, 2) Positive predictive value of real-time near-infrared fluorescence imaging to detect microscopic residual disease in real time in the operating bed after excision, 3) Tumor/background ratio (TBR) mapping and kinetic, 4) Number of patients with adverse events and their grade to measure safety and tolerability, 5) Differences between evaluation criteria measured in open surgery and transoral robotic surgery.;Timepoint(s) of evaluation of this end point: 1), 2), 3), and 5) secondary end points : real-time 4) secondary end point : 30 days +/- 5 days after the surgery | — |
Countries
France
Contacts
Public ContactSponsor CRA
Gustave Roussy
Outcome results
None listed