Ultra-Violet Fluorescence Bronchial Cancer Location (UVFBCL)
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rigid bronchoscopy with ultraviolet transmission
Biopsy
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer
Eligibility Criteria
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.
Sites / Locations
- Pneumology departement CHU Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients with lung cancer
Arm Description
Outcomes
Primary Outcome Measures
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).
Histology of tissue
The histology give the final diagnosis
Secondary Outcome Measures
Full Information
NCT ID
NCT02533518
First Posted
August 17, 2015
Last Updated
August 24, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02533518
Brief Title
Ultra-Violet Fluorescence Bronchial Cancer Location
Acronym
UVFBCL
Official Title
Ultra-Violet Fluorescence Bronchial Cancer Location
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with lung cancer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Rigid bronchoscopy with ultraviolet transmission
Intervention Type
Other
Intervention Name(s)
Biopsy
Primary Outcome Measure Information:
Title
ultraviolet fluorescence ratio Iodine360 / Iodine450
Description
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).
Time Frame
Day 0
Title
Histology of tissue
Description
The histology give the final diagnosis
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pneumology departement CHU Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Learn more about this trial
Ultra-Violet Fluorescence Bronchial Cancer Location
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