LIFE-Lung Bronchoscopy in Patients at Risk for Developing Lung Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Chronic Obstructive Pulmonary Disease, Pulmonary |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 9/15/2018 |
| Start Date: | August 1998 |
| End Date: | March 2017 |
LIFE-Lung Fluorescence Endoscopic Surveillance in Patients at High Risk For Developing Lung Cancer
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.
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.
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.
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
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.
We found this trial at
1
site
5115 Centre Avenue
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
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