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
18 Years
N/A
Both
Head and Neck Cancer, Lung Cancer
Trial Information
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
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Screening
Principal Investigator
J. Michael Hamilton, MD
Investigator Role:
Study Chair
Investigator Affiliation:
National Cancer Institute (NCI)
Authority:
United States: Federal Government
Study ID:
CDR0000065062
NCT ID:
NCT00019201
Start Date:
August 1996
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Lung Cancer
- 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
- Head and Neck Neoplasms
- Lung Neoplasms
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
