Ultra-Violet Fluorescence Bronchial Cancer Location

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Procedure: Rigid bronchoscopy with ultraviolet transmission; Other: Biopsy

• Registration Number: NCT02533518
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.

The purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-24
• Last Update Submitted: 2015-08-24
• Study First Posted: 2015-08-26
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient affiliated or entitled to a social security scheme
• Major Patient
• Patient who signed the informed consent document
• Patient with a known primary cancer in bronchial level

Exclusion Criteria

• Pregnant woman
• Patient with a benign tumor histology
• Patient with an unknown tumor histology.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with lung cancer	Biopsy	-
patients with lung cancer	Rigid bronchoscopy with ultraviolet transmission	-

Primary Outcome Measures

Name	Time	Method
Histology of tissue	Day 0	The histology give the final diagnosis
ultraviolet fluorescence ratio Iodine360 / Iodine450	Day 0	Detection of cancerous tissues and healthy or inflammatory tissues is used to calculate the sensitivity and specificity of the rigid bronchoscopy with UV transmission compared to biopsy (gold standard).

Trial Locations

Locations (1)

Pneumology departement CHU Saint-Etienne; 🇫🇷 Saint-etienne, France