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

National Cancer Institute (NCI)

Status: Completed

Conditions: Lung Cancer; Head and Neck Cancer

Treatments: Procedure: endoscopic biopsy; Other: immunohistochemistry staining method; Procedure: comparison of screening methods; Other: sputum cytology; Procedure: bronchoscopy; Other: cytology specimen collection procedure; Procedure: bronchoscopic and lung imaging studies

Study type: Interventional

Funder types: NIH

Identifiers

NCT00019201

CDR0000065062

NCI-96-C-0128

Details and patient eligibility

About

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.

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)