Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019201
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PILOT STUDY OF THE CORRELATION BETWEEN THE FINDINGS OF ATYPICALMALIGNANT CELLS IN SPUTUM AND FLUORESCENCE BRONCHOSCOPY IN PATIENTS AT RISK FOR LUNG CANCER OF THE LIFE IMAGING SYSTEM AND WHITE LIGHT BRONCHOSCOPY
Status:
COMPLETED
Status Verified Date:
2000-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Fluorescent bronchoscopy when used in combination with conventional white light bronchoscopy may improve the ability to detect early lung cancer
PURPOSE A pilot study to evaluate fluorescent light bronchoscopy plus conventional bronchoscopy as a tool for screening and detecting lung cancer in persons with completely resected head and neck cancer or successfully treated early-stage lung cancer
PURPOSE A pilot study to evaluate fluorescent light bronchoscopy plus conventional bronchoscopy as a tool for screening and detecting lung cancer in persons with completely resected head and neck cancer or successfully treated early-stage lung cancer
Detailed Description:
OBJECTIVES
Evaluate the efficacy of autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic System with conventional white-light bronchoscopy for the early detection of lung cancer in selected patients with known or suspected bronchogenic carcinoma completely resected head and neck cancer and successfully treated early-stage lung cancer
Determine the number of areas of moderate dysplasia severe dysplasia and carcinoma in situ in patients treated with surgery for lung cancer compared with patients treated with combined modality therapy
Determine the ability of immunohistochemistry to predict whether lesions of moderate to severe dysplasia will progress to cancer
OUTLINE If possible patients produce a 3-day pooled sputum sample prior to bronchoscopy Patients then undergo tracheobronchial white-light bronchoscopy followed by autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic LIFE Device attached to a computerized video camera Visualized tissue is classified as either normal abnormal or suspicious Abnormal or suspicious tissue is biopsied as is tissue from 1 or 2 randomly chosen normal sites Immunohistochemical analysis of the biopsy material is conducted without knowledge of the bronchoscopic results Patients unable to produce a sputum sample prior to bronchoscopy are required to do so after bronchoscopy
PROJECTED ACCRUAL A total of 70 patients will be entered
Evaluate the efficacy of autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic System with conventional white-light bronchoscopy for the early detection of lung cancer in selected patients with known or suspected bronchogenic carcinoma completely resected head and neck cancer and successfully treated early-stage lung cancer
Determine the number of areas of moderate dysplasia severe dysplasia and carcinoma in situ in patients treated with surgery for lung cancer compared with patients treated with combined modality therapy
Determine the ability of immunohistochemistry to predict whether lesions of moderate to severe dysplasia will progress to cancer
OUTLINE If possible patients produce a 3-day pooled sputum sample prior to bronchoscopy Patients then undergo tracheobronchial white-light bronchoscopy followed by autofluorescence bronchoscopy using the Lung Imaging Fluorescence Endoscopic LIFE Device attached to a computerized video camera Visualized tissue is classified as either normal abnormal or suspicious Abnormal or suspicious tissue is biopsied as is tissue from 1 or 2 randomly chosen normal sites Immunohistochemical analysis of the biopsy material is conducted without knowledge of the bronchoscopic results Patients unable to produce a sputum sample prior to bronchoscopy are required to do so after bronchoscopy
PROJECTED ACCRUAL A total of 70 patients will be entered
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-96-C-0128 | None | None | None |