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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00019201
Enrollment
Unknown
Registered
2003-01-27
Start date
1996-08-31
Completion date
Unknown
Last updated
2015-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERcytology specimen collection procedure
OTHERimmunohistochemistry staining method
PROCEDUREbronchoscopy
PROCEDUREendoscopic biopsy

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
SCREENING

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026