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


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Lung Cancer

Thank you

Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

J. Michael Hamilton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000065062

NCT ID:

NCT00019201

Start Date:

August 1996

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Lung Cancer
  • 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
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182