The purpose of this research is to evaluate and determine the rate of successful administration of Percussive ventilation breathhold (PVB) to allow for more accurate radiotherapy for lung tumors.
Primary Objective(s) * To determine the rate of successful administration of the PVB-SABR in lung cancer patients. * To determine the rate of successful administration of PVB in healthy volunteers for 5 minutes Secondary Objective(s) * To determine the rate of successful administration of PVB in healthy volunteers for 10 minutes as well as for patients' successfully completing the technique for 5 and 10 minutes. * To collect exploratory clinical (both arms) and dosimetric data from lung cancer patients using PVB-SABR.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment
Stanford Cancer Institute
Palo Alto, California, United States
RECRUITINGRate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.
The rate will be measured as the proportion of healthy volunteers who can be successfully execute the Percussive Ventilation Breathhold for 5 minutes. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis.
Time frame: 18 months
Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) in lung patients.
The rate will be measured as the proportion of lung cancer patients who successfully complete treatment using the PVB SABR method as defined by 100% of the prescribed Stereotactic Ablative Radiotherapy dose being delivered using the Percussive Ventilation Breathhold (PVB) technique. A failure will be defined as a patient who fails to use the method for any part of the treatment. In the event of a failure, both investigator and patient will be asked to specify the reason for failure for purposes of failure analysis.
Time frame: 18 months
Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients
The rates will be measured as the proportion of healthy volunteers who can be successfully execute the PV breathhold for 10 minutes
Time frame: 3 months
Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique
We will collect optional exploratory noninvasive clinical data during PVB including but not limited to real-time CO2 and SpO2 data (using the SenTec Digital Monitoring System or similar device) and surface anatomy monitoring (using devices such as Kinect camera, vision-RT, or laser surface monitoring system). All of these data will be collected on an optional exploratory basis.
Time frame: 3 months
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