Malignant Pharyngo Laryngeal Tumors Clinical Trial
— MEC ORLOfficial title:
Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer
| Verified date | February 2021 |
| Source | Gustave Roussy, Cancer Campus, Grand Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | May 24, 2017 |
| Est. primary completion date | May 24, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Institut Universitaire Du Cancer de Toulouse - Oncopole | Toulouse | |
| France | Institut Gustave Roussy | Villejuif | Val De Marne |
| Lead Sponsor | Collaborator |
|---|---|
| Gustave Roussy, Cancer Campus, Grand Paris | Ministry of Health, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnostic correlation between confocal micro endoscopy and conventional histology | at an average of 18 months | ||
| Secondary | Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis | At the time of the biopsy |