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

NCT ID: NCT00019201

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-08-31

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.

Conditions

Head and Neck Cancer; Lung Cancer

Study Design

• Primary Study Purpose: SCREENING

Interventions

cytology specimen collection procedure

Intervention Type: OTHER

immunohistochemistry staining method

Intervention Type: OTHER

sputum cytology

Intervention Type: OTHER

bronchoscopic and lung imaging studies

Intervention Type: PROCEDURE

bronchoscopy

Intervention Type: PROCEDURE

comparison of screening methods

Intervention Type: PROCEDURE

endoscopic biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

J. Michael Hamilton, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-96-C-0128

Identifier Type: -

Identifier Source: secondary_id

CDR0000065062

Identifier Type: -

Identifier Source: org_study_id

NCT00001511

Identifier Type: -

Identifier Source: nct_alias