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

Stopped early · Phase 2

Conditions studied: Non-Small-Cell Lung Carcinoma, Head and Neck Squamous Cell Cancer, Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00260598

Run by

University of Pittsburgh

People needed

142

Starts

1998-08-01

Expected to finish

2017-03-01

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Hillman Cancer Center of the University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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