Ultra-Violet Fluorescence Bronchial Cancer Location

NCT02533518 | Completed

• 2 other identifiers: 10080412010-A00343-36
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Histology of tissue

  The histology give the final diagnosis

  Day 0

Study Arms (1)

patients with lung cancer

EXPERIMENTAL

Procedure: Rigid bronchoscopy with ultraviolet transmission; Other: Biopsy

Interventions

Rigid bronchoscopy with ultraviolet transmission PROCEDURE

patients with lung cancer

Biopsy OTHER

patients with lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Pneumology departement CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 26, 2015
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

FR (1)