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LIFE-Lung Fluorescence Endoscopic Surveillance in Patients at High Risk For Developing Lung Cancer

Phase 2
18 Years
85 Years
Not Enrolling
Non-Small-Cell Lung Carcinoma, Head and Neck Squamous Cell Cancer, Pulmonary Disease, Chronic Obstructive

Thank you

Trial Information

LIFE-Lung Fluorescence Endoscopic Surveillance in Patients at High Risk For Developing Lung Cancer

The North American Lung Cancer Study Group showed that Stage I (T1,N0,M0) non small cell
lung carcinoma patients who have undergone complete surgical resection have a 60-70%
five-year survival but have a 3.6% per year risk of developing a second lung primary cancer.
Data from the Mayo Clinic on patients that underwent surgical resection for sputum cytology
positive but radiologically occult lung cancer found that second primary lung cancers
occurred at a rate as high as 5% per year in this patient population. In a collective review
of 1406 patients with occult or stage I completely resected lung carcinomas, the incidence
of second-primary lung cancers was 11.4% (range 3-30%). The mortality from second-primary
lung carcinomas in surgical patients is much higher than for the first tumor because
treatment is both more limited and complicated as a consequence of their prior lung
resection. Second NSCLC primaries are a particularly vexing treatment dilemma in patients
who have undergone a prior curative, surgical resection because of their limited, residual
pulmonary reserve.

White light bronchoscopy (WLB) has been shown to be a useful tool in localizing
radiographically occult lesions. However, Woolner et al. demonstrated that only 29% of
carcinoma in situ (CIS) and 69% of micro-invasive tumors are identified by experienced
bronchoscopists. In 1996 an endoscopic lung imaging system developed by the British Columbia
Cancer Research Centre in conjunction with Xillix Technologies Corp., known as the LIFE-lung
Fluorescence Endoscopy System was approved by the FDA. LIFE-lung bronchoscopy is performed
with a helium-cadmium laser using blue light @ 442 nm for illumination and allows
visualization of these differences in normal and abnormal tissue autofluorescence. Lam and
others have shown that the tissue autofluorescence spectra of areas of dysplasia and
carcinoma in situ differ significantly from those of normal bronchial tissues.
Specifically, LIFE Bronchoscopy improved sensitivity of detection of metaplasia and
dysplasia by 171% over current WLB. LIFE bronchoscopy's sensitivity for the detection of CIS
is 500% greater than that of standard WLB.

Fluorescence bronchoscopy using the LIFE system is identical to standard flexible
bronchoscopy except that it utilizes blue light (from a Helium-Cadmium light source) in
contrast to white light (commonly emitted from a Xenon or Halogen light source). Both
fluorescent and reflected light are produced when the bronchial surface is illuminated by
visible light, the difference is that with the LIFE-lung system, the image is reconstructed
from emitted fluorescent light instead of from light reflected off of the bronchial surface.
Emitted fluorescence and reflective light are separated by appropriate filters.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

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

Outcome Time Frame:

Throughout course of study

Safety Issue:


Principal Investigator

Neil A. Christie, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Heart, Lung, and Esophageal Surgery Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Head and Neck Squamous Cell Cancer
  • Pulmonary Disease, Chronic Obstructive
  • 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)
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Chronic Disease
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Lung Neoplasms



Hillman Cancer Center of the University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213