Trial Information
Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer
Inclusion Criteria:
- Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct
laryngoscopy was performed under general anesthesia with biopsies for diagnostic or
endoscopic removal
- > 18 years
- signed ICF
Exclusion Criteria:
- Patients on beta-blocker treatment
- Patients with history of allergy to patent blue
- Pregnant women
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Primary Purpose: Diagnostic
Outcome Measure:
Diagnostic correlation between confocal micro endoscopy and conventional histology
Outcome Time Frame:
at an average of 18 months
Safety Issue:
No
Principal Investigator
Stéphane TEMAM, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gustave Roussy, Cancer Campus, Grand Paris
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
2011-A00818-33
NCT ID:
NCT01626638
Start Date:
September 2012
Completion Date:
September 2014
Related Keywords:
- Malignant Pharyngo Laryngeal Tumors
- Pre-malignant Pharyngo Laryngeal Tumors
- Patients with malignant and pre-malignant pharyngo laryngeal tumors
- Head and Neck Neoplasms
- Laryngeal Neoplasms
- Precancerous Conditions