Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


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)


NCT ID:

NCT00019201


Primary Contact:

Study Chair
J. Michael Hamilton, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2017

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