Respiration Gated Laser Guided CT Lung Nodule Biopsy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Accuracy of respiration gated laser guided CT lung nodule biopsy
Study Overview
Brief Summary
The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system. Secondary outcome is the rate of complications using laser guided CT biopsy in general and with bellows-based breath hold monitoring system. The study has approval from the The Danish National Committee on Biomedical Research Ethics (ref no: H-4-2010-fsp 1).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with indeterminate lung nodules referred from the department of pulmonary medicine at Gentofte Hospital, Denmark for a CT guided biopsy are considered for inclusion in this study. The biopsy was preformed as part of regular clinical work up of the patient at the department of Radiology Gentofte Hospital, Denmark. Both men and women were included and no age restrictions were applied.
Exclusion Criteria
- •Excluded from biopsy were those with poor pulmonary function test with a forced expired volume in the first second (FEV1) < 0.5 L, INR>1.2, blood cloth level under 200* and ECG with sign of ischemic heart disease. The trial is planned to begin 1.March 2010 and run for 2 years ending at 29 February
- •During this time approx. 400 participants planned for biopsy are accepted to be included in the trial.
Outcomes
Primary Outcomes
Accuracy of respiration gated laser guided CT lung nodule biopsy
Time Frame: After 2 years
The primary outcome of this study is to investigate the accuracy of respiration gated laser guided CT lung nodule biopsy through a prospective randomized trial using a bellows-based breath hold monitoring system.
Secondary Outcomes
No secondary outcomes reported