ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01626638
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Pharyngo Laryngeal Tumors Pre-malignant Pharyngo Laryngeal Tumors Procedure: Confocal Micro Endoscopy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : May 24, 2017
Actual Study Completion Date : May 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental Procedure: Confocal Micro Endoscopy



Primary Outcome Measures :
  1. Diagnostic correlation between confocal micro endoscopy and conventional histology [ Time Frame: at an average of 18 months ]

Secondary Outcome Measures :
  1. Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis [ Time Frame: At the time of the biopsy ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626638


Locations
France
Institut Gustave Roussy
Villejuif, Val De Marne, France, 94805
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

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01626638     History of Changes
Other Study ID Numbers: 2011-A00818-33
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

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

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