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Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer

Primary Purpose

Head and Neck Cancer, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cytology specimen collection procedure
immunohistochemistry staining method
sputum cytology
bronchoscopic and lung imaging studies
bronchoscopy
comparison of screening methods
endoscopic biopsy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Head and Neck Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage III non-small cell lung cancer, limited stage small cell lung cancer, stage I nasopharyngeal cancer, stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage I lip and oral cavity cancer, stage II lip and oral cavity cancer, stage III lip and oral cavity cancer, stage I hypopharyngeal cancer, stage II hypopharyngeal cancer, stage III hypopharyngeal cancer, stage I laryngeal cancer, stage II laryngeal cancer, stage III laryngeal cancer, stage I paranasal sinus and nasal cavity cancer, stage II paranasal sinus and nasal cavity cancer, stage III paranasal sinus and nasal cavity cancer, stage I oropharyngeal cancer, stage II oropharyngeal cancer, stage III oropharyngeal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: The following diagnoses are eligible: Known or suspected bronchogenic carcinoma scheduled for bronchoscopy as part of standard diagnostic or staging work-up Completely resected stage I/II non-small cell lung cancer with no evidence of metastasis Stage III non-small cell lung cancer with no evidence of disease for at least 2 years following treatment Small cell lung cancer with no evidence of disease for at least 2 years following treatment Completely resected head and neck cancer with no evidence of metastasis Ability to produce sputum samples required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC 2,000-20,000 Platelets at least 50,000 Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (i.e., systolic pressure greater than 200 mm Hg or diastolic pressure greater than 120 mm Hg) No unstable angina Other: No bleeding disorder No allergic reaction to topical lidocaine No pregnant women PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy At least 18 months since ionizing radiotherapy to the chest Surgery See Disease Characteristics Other At least 1 month since yttrium-aluminum-garnet (YAG) laser therapy to the lung At least 3 months since fluorescent photosensitizing drugs (e.g., Photofrin)

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019201
Brief Title
Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer
Official Title
PILOT STUDY OF THE CORRELATION BETWEEN THE FINDINGS OF ATYPICAL/MALIGNANT CELLS IN SPUTUM AND FLUORESCENCE BRONCHOSCOPY IN PATIENTS AT RISK FOR LUNG CANCER OF THE LIFE IMAGING SYSTEM AND WHITE LIGHT BRONCHOSCOPY
Study Type
Interventional

2. Study Status

Record Verification Date
February 2000
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage III non-small cell lung cancer, limited stage small cell lung cancer, stage I nasopharyngeal cancer, stage II nasopharyngeal cancer, stage III nasopharyngeal cancer, stage I lip and oral cavity cancer, stage II lip and oral cavity cancer, stage III lip and oral cavity cancer, stage I hypopharyngeal cancer, stage II hypopharyngeal cancer, stage III hypopharyngeal cancer, stage I laryngeal cancer, stage II laryngeal cancer, stage III laryngeal cancer, stage I paranasal sinus and nasal cavity cancer, stage II paranasal sinus and nasal cavity cancer, stage III paranasal sinus and nasal cavity cancer, stage I oropharyngeal cancer, stage II oropharyngeal cancer, stage III oropharyngeal cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
sputum cytology
Intervention Type
Procedure
Intervention Name(s)
bronchoscopic and lung imaging studies
Intervention Type
Procedure
Intervention Name(s)
bronchoscopy
Intervention Type
Procedure
Intervention Name(s)
comparison of screening methods
Intervention Type
Procedure
Intervention Name(s)
endoscopic biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: The following diagnoses are eligible: Known or suspected bronchogenic carcinoma scheduled for bronchoscopy as part of standard diagnostic or staging work-up Completely resected stage I/II non-small cell lung cancer with no evidence of metastasis Stage III non-small cell lung cancer with no evidence of disease for at least 2 years following treatment Small cell lung cancer with no evidence of disease for at least 2 years following treatment Completely resected head and neck cancer with no evidence of metastasis Ability to produce sputum samples required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC 2,000-20,000 Platelets at least 50,000 Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (i.e., systolic pressure greater than 200 mm Hg or diastolic pressure greater than 120 mm Hg) No unstable angina Other: No bleeding disorder No allergic reaction to topical lidocaine No pregnant women PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy At least 18 months since ionizing radiotherapy to the chest Surgery See Disease Characteristics Other At least 1 month since yttrium-aluminum-garnet (YAG) laser therapy to the lung At least 3 months since fluorescent photosensitizing drugs (e.g., Photofrin)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Michael Hamilton, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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Fluorescent Light Bronchoscopy Plus White Light Bronchoscopy for Early Detection of Lung Cancer

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