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Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL) (MEC ORL)

This study is not yet open for participant recruitment.
Verified January 2012 by Institut Gustave Roussy
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT01626638
First received: June 15, 2012
Last updated: September 3, 2012
Last verified: January 2012
History of Changes
  Purpose

The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.


Condition Intervention
Malignant Pharyngo Laryngeal Tumors
Pre-malignant Pharyngo Laryngeal Tumors
 Procedure: Confocal Micro Endoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Diagnostic correlation between confocal micro endoscopy and conventional histology [ Time Frame: at an average of 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis [ Time Frame: At the time of the biopsy ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626638

Locations
France
Institut Gustave Roussy Not yet recruiting
Villejuif, Val de Marne, France, 94805
Contact: Stéphane TEMAM, MD     +33 1 42 11 44 46        
Principal Investigator: Stéphane TEMAM, MD            
Sponsors and Collaborators
Institut Gustave Roussy
Ministry of Health, France
Investigators
Principal Investigator: Stéphane TEMAM, MD Institut Gustave Roussy
  More Information

No publications provided

Responsible Party: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT01626638     History of Changes
Other Study ID Numbers: 2011-A00818-33
Study First Received: June 15, 2012
Last Updated: September 3, 2012
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé

Keywords provided by Institut Gustave Roussy:
Patients with malignant and pre-malignant pharyngo laryngeal tumors

Additional relevant MeSH terms:
Head and Neck Neoplasms
Laryngeal Neoplasms
Precancerous Conditions
Neoplasms by Site
Neoplasms
 Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013