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LIFE-Lung Bronchoscopy in Patients at Risk for Developing Lung Cancer

NCT00260598 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-09-13

No results posted yet for this study

Summary

The purpose of the study is to evaluate the usefulness and accuracy of the "LIFE-Lung Bronchoscopy" to identify early changes in lung tissues that show precancerous, cancer in situ (just beginning and not spread) and microscopic invasive cancer lesions versus the ability of the standard "White Light Bronchoscopy" to identify the same. This will be done as a part of routine monitoring bronchoscopy.

Patients who have had a surgical resection of non-small cell lung cancer (NSCLC) and with no current evidence of disease (NED) will be eligible. Also eligible are patients who have had head or neck squamous cell carcinoma with radical head and/or neck dissection and who are currently NED. Patients with severe chronic, obstructive, pulmonary disease shown by pulmonary function testing abnormalities will also be eligible.

In addition to the specialized bronchoscopy, doctors will be investigating the use of imaging spectroscopy. This is using an optical (visualizing) procedure to measure the light reflected back from tissue. Different lesions and normal tissues reflect light differently and in specific color wavelengths. By using measurements over time (different examinations/bronchoscopies) very small changes can be seen. This may allow eventually for very early diagnosing of precancerous or cancer in situ lesions, allowing for earlier treatment.

Conditions

  • Non-Small-Cell Lung Carcinoma
  • Head and Neck Squamous Cell Cancer
  • Pulmonary Disease, Chronic Obstructive

Interventions

PROCEDURE

LIFE Bronchoscopy

The first LIFE Bronchoscopy is performed at least 6 months following surgical resection of primary NSCLC. Timing of subsequent bronchoscopies is dependent on pathology from first bronchoscopy.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Neil A. Christie, MD · Heart, Lung, and Esophageal Surgery Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-08-31
Primary Completion
2010-01-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00260598 on ClinicalTrials.gov