None listed
Conditions
Interventions
Trade Name: VERDE INDOC.PULS.*INIET 5FL25M
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: INDOCYANINE GREEN
CAS Number: 3599-32-4
Concentration unit: mg/ml milligram(s)/mi
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male e Female of age = 18 years old. Histological confirmed diagnosis of epithelial tumors of the oral cavity. Primary tumor cT4 candidate to major surgery with cervical access. Absence of clinically positive lymph nodes. Absence of previous treatments. Signed Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: Hypersensitivity / known allergy to ICG, sodium iodide or iodine; Hyperthyroidism; Thyroid carcinoma; Pregnancy and / or lactation; Taking drugs that affect liver function; Renal failure; Taking medications that can alter the absorption of indocyanine-green; Psychiatric disorders or any disease that compromises the ability to provide informed consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Validation of the new method, the fluorescence lymphography, by direct comparison with the gold standard method, the radio colloid.;Secondary Objective: na;Primary end point(s): diagnostic sensibility in terms of true and false positive and false negative;Timepoint(s) of evaluation of this end point: At the time of the histopathological evaluation of the lymphonodes obtained during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Positive predictive value (PPV);Timepoint(s) of evaluation of this end point: at the end of the study | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed