Lung Cancer Clinical Trial

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

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.

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Full 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.

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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

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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)

Study is for people with:

Lung Cancer

Study ID:

NCT00019201

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Study ID:

NCT00019201

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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