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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1996
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019201

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: J. Michael Hamilton, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00019201     History of Changes
Obsolete Identifiers: NCT00001511
Other Study ID Numbers: CDR0000065062, NCI-96-C-0128
Study First Received: July 11, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Lung Neoplasms
Neoplasms by Site
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014