Status:
WITHDRAWN
Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease
Lead Sponsor:
Lahey Clinic
Collaborating Sponsors:
Massachusetts General Hospital
National Institutes of Health (NIH)
Conditions:
Squamous Cell Lung Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the potential of a new imaging device, termed Optical Frequency Domain Imaging (OFDI), in the early diagnosing of pulmonary malignancies in the central airways.
Detailed Description
This study will evaluate the potential of a new imaging device, the Optical Frequency Domain Imaging (OFDI) for imaging pulmonary malignancy in the central airways. The prevalence and high mortality ...
Eligibility Criteria
Inclusion
- Patients undergoing bronchoscopy for known or suspected pulmonary malignancy in the central airways
- Patients must be over the age of 18
- Patient must be able to give informed consent
- Women with child bearing potential must have a negative pregnancy test within seven days prior to the procedure
Exclusion
- PaO2 less than 80 on FiO2 greater 70%
- Systolic blood pressure less than 90
- Active bronchospasm
- INR greater than 2.0 (INR: International Normalized Ratio)
- Recent myocardial infarction within last two weeks
- Active cardiac chest pain
- Significant untreated sleep apnea
- FEV1 less than 30% of predicted (FEV1: forced expiratory volume in 1 second)
- Worsening hypercarbia with PaCO2 greater than 55
- In active respiratory failure (unless endotracheal intubation is performed first to stabilize the airway)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00784329
Start Date
March 1 2008
End Date
December 1 2018
Last Update
March 12 2019
Active Locations (1)
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1
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805