LIFE-Lung Bronchoscopy in Patients at Risk for Developing Lung Cancer (NCT00260598) | Clinical Trial Compass
TerminatedPhase 2
LIFE-Lung Bronchoscopy in Patients at Risk for Developing Lung Cancer
Stopped: LIFE Bronchoscopy equipment no longer functioning and cannot be repaired.
United States142 participantsStarted 1998-08
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 system…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.