Non-Small-Cell Lung CarcinomaPhase 2NCT00260598
LIFE-Lung Bronchoscopy in Patients at Risk for Developing Lung Cancer
A Phase 2 study testing LIFE Bronchoscopy in people with Non-Small-Cell Lung Carcinoma and Head and Neck Squamous Cell Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma, Head and Neck Squamous Cell Cancer, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- LIFE Bronchoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center of the University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Non-Small-Cell Lung Carcinoma, Head and Neck Squamous Cell Cancer, Pulmonary Disease, Chronic Obstructive
- Being tested
- LIFE Bronchoscopy
- 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)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pulmonary Disease, Chronic Obstructive, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFE BronchoscopyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the differences in the detection rate for moderate and severe dysplasia as well as CIS between LIFE-Lung fluorescence and white light bronchoscopy.
Measured: Throughout course of study
Secondary outcomes (1)
To determine the false positive rate of white light bronchoscopy and LIFE-lung bronchoscopy.
Measured: Throughout course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startAug 1998
- Primary completionJan 2010
- Study completionMar 2017
Why it stopped: LIFE Bronchoscopy equipment no longer functioning and cannot be repaired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Neil Christie, University of Pittsburgh
- Investigators
- Neil A. Christie, MD, Principal investigator, Heart, Lung, and Esophageal Surgery Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260598
- Sponsor's protocol ID
- 01-1030
- Status last verified
- Sep 2018
- First submitted
- 29 Nov 2005
- Last updated
- 13 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFE-Lung Fluorescence Endoscopic Surveillance in Patients at High Risk For Developing Lung Cancer
- ClinicalTrials.gov ID
- NCT00260598
- Acronym / sponsor ID
- 01-1030
- 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)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: LIFE Bronchoscopy equipment no longer functioning and cannot be repaired.
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 1998
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIFE BronchoscopyThe 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. | Procedure or surgery | – |
Primary outcome
Measure the differences in the detection rate for moderate and severe dysplasia as well as CIS between LIFE-Lung fluorescence and white light bronchoscopy.
Time frame: Throughout course of study
1 secondary outcome
To determine the false positive rate of white light bronchoscopy and LIFE-lung bronchoscopy.
Time frame: Throughout course of study
Results and safety
The study was stopped early (reason given: LIFE Bronchoscopy equipment no longer functioning and cannot be repaired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil A. Christie, MD principal investigator
Heart, Lung, and Esophageal Surgery Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LIFE Bronchoscopy in people with Non-Small-Cell Lung Carcinoma and Head and Neck Squamous Cell Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: LIFE Bronchoscopy equipment no longer functioning and cannot be repaired.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: Throughout course of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.