Ultra-Violet Fluorescence Bronchial Cancer Location

Lung Cancer Clinical Trial

— UVFBCL  

Official title:

Ultra-Violet Fluorescence Bronchial Cancer Location

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533518
• Other study ID #: 1008041
• Secondary ID: 2010-A00343-36
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: August 24, 2015
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma, Bronchogenic
• Lung Cancer

Intervention

Procedure:
• Rigid bronchoscopy with ultraviolet transmission

Other:
• Biopsy

Locations

Country	Name	City	State
France	Pneumology departement CHU Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultraviolet fluorescence ratio Iodine360 / Iodine450	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).	Day 0	No
Primary	Histology of tissue	The histology give the final diagnosis	Day 0	No