Health Condition 1: C021- Malignant neoplasm of border of tongue
Conditions
Interventions
Intervention1: Cetuximab ICG nano probe: phase 1-The patients will be divided into 3 cohort groups
All the cohorts will receive an infusion of 75mg of unlabelled Cetuximab to prevent rapid clearance. Cohort 1 will receive a micro dose of Cetuximab ICG nanoparticle conjugate at 2.5 mg/m2 (1/100 of
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: Age more than or equal to 18 years ECOG performance status 0 1 or Karnofsky Performance Status more than 70 Biopsy-confirmed T1,T2,T3 oral tongue squamous cell carcinoma Planned for curative-intent surgical resection
Exclusion criteria
Exclusion criteria: Electrolyte abnormalities (magnesium less than 1.3 mEq/L, potassium less than 3.5 mEq/L) Prior hypersensitivity to monoclonal antibodies Significant hepatic, renal or cardiovascular disease Use of class IA or III antiarrhythmic drugs Evidence of distant metastasis History of QT prolongation or use of QT-prolonging drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of negative surgical margins (more than or equal to 5 mm) comparing conventional versus fluorescence-guided surgeryTimepoint: 4 weeks after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (CTCAE grading) Timepoint: 4 weeks post surgery;Diagnostic accuracy (sensitivity and specificity) Timepoint: 4 weeks post surgery ;Diagnostic accuracy (sensitivity and specificity) Feasibility of intraoperative imaging to detect the tumors Timepoint: 4 weeks post surgery;Detection of second primary tumoursTimepoint: 4 weeks post surgery | — |
Countries
India
Contacts
Public ContactLakshmi Menon R
Amrita institute of medical sciences
Outcome results
None listed