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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019201
First received: July 11, 2001
Last updated: February 6, 2009
Last verified: February 2000

July 11, 2001
February 6, 2009
August 1996
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Complete list of historical versions of study NCT00019201 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Not Provided
Primary Purpose: Screening
  • Head and Neck Cancer
  • Lung Cancer
  • Other: cytology specimen collection procedure
  • Other: immunohistochemistry staining method
  • Other: sputum cytology
  • Procedure: bronchoscopic and lung imaging studies
  • Procedure: bronchoscopy
  • Procedure: comparison of screening methods
  • Procedure: endoscopic biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019201
CDR0000065062, NCI-96-C-0128
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National Cancer Institute (NCI)
Not Provided
Study Chair: J. Michael Hamilton, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
February 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP