Status:
TERMINATED
LIFE-Lung Bronchoscopy in Patients at Risk for Developing Lung Cancer
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Non-Small-Cell Lung Carcinoma
Head and Neck Squamous Cell Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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...
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 hav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00260598
Start Date
August 1 1998
End Date
March 1 2017
Last Update
September 13 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hillman Cancer Center of the University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213