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

NCT00260598 | Terminated Phase 2

• 1 other identifier: 01-1030
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Non-small cell lung cancer; Head and neck squamous cell cancer; White light bronchoscopy; Imaging Elastic Scattering Spectroscopy (IESS); Fluorescence Bronchoscopy; COPD; Helium-Cadmium Laser Bronchoscopy; Autofluorescence spectra of dysplasia & cancer in situ (CIS); Severe Chronic Obstructive Pulmonary Disorders(COPD)

Outcome Measures

Primary Outcomes (1)

• Measure the differences in the detection rate for moderate and severe dysplasia as well as CIS between LIFE-Lung fluorescence and white light bronchoscopy.

  Throughout course of study

Secondary Outcomes (1)

• To determine the false positive rate of white light bronchoscopy and LIFE-lung bronchoscopy.

  Throughout course of study

Interventions

LIFE Bronchoscopy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with non-small cell lung cancer (NSCLC) who have undergone surgical resection, via a lobectomy, pneumonectomy, or wedge resection and currently have no evidence of disease (NED).
• Persons with head/neck squamous cell cancer who have undergone radical head and/or neck resection and who currently have NED.
• Persons with severe chronic, obstructive, pulmonary disease as evidenced by pulmonary function abnormalities: i.e. FEV1 \< 50%predicted; RV \> 200% predicted and/or DLCO \< 40% predicted.

You may not qualify if:

• Persons with uncontrolled hypertension (systolic pressure \>200mmHG, diastolic pressure \>120 mm HG)
• Persons with unstable angina.
• Persons with known or suspected pneumonia.
• Persons with acute bronchitis within one month of the procedure.
• Persons who have received neoadjuvant or adjuvant chemo- or radio-therapy within the past six months.
• Persons with white blood count (WBC) less than 2000 or greater than 20,000 and/or platelet count less than 50,000.
• Persons with any known bleeding dyscrasia.
• Persons who have received fluorescent photosensitizing drugs such as Photofrin within one month of the procedure.
• Persons with a known allergic reaction to topical xylocaine (lidocaine).
• Persons who have received or are on chemopreventive drugs (i.e. retinoic acid) within one month of the procedure.
• Persons who have received ionizing radiation to the chest within six months of the procedure.
• Persons who have received systemic cytotoxic chemotherapeutic agents within the past six months.
• Persons who are pregnant or nursing. All women of childbearing potential must have a negative serum pregnancy test prior to enrollment.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Hillman Cancer Center of the University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pulmonary Disease, Chronic Obstructive; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Neil A. Christie, MD

  Heart, Lung, and Esophageal Surgery Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: August 1, 1998
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2017
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

US (1)