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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01626638
First received: June 15, 2012
Last updated: February 9, 2016
Last verified: February 2016
  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
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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: February 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Procedure: Confocal Micro Endoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  • Persons deprived of liberty
  • Patients with history of allergy to patent blue
  • Pregnant women or breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Institut Gustave Roussy 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
Gustave Roussy, Cancer Campus, Grand Paris
Ministry of Health, France
Investigators
Principal Investigator: Stéphane TEMAM, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01626638     History of Changes
Other Study ID Numbers: 2011-A00818-33 
Study First Received: June 15, 2012
Last Updated: February 9, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Patients with malignant and pre-malignant pharyngo laryngeal tumors

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

ClinicalTrials.gov processed this record on August 24, 2016