Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. To collect patient-reported data on hospital-associated anxiety, motivation to learn the technique from the educational materials, and subjective evaluation of those materials

Official Title
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A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Percussive Ventilation Breathhold SABR (PVB-SABR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers age 18 or older Patients with a diagnosis of primary lung cancer or lung metastases of any primary tumor origin Patients deemed clinically eligible to be treated with standard of care lung SABR for patient arm Patients of any gender age 18 or older Patients with ECOG Performance Status 1-2 and select patients with Performance Status 3 deemed to be suitable candidates based on common sense clinical judgment on the risks versus benefits of SABR Exclusion Criteria: No Pregnant Women Patients clinically deemed ineligible for standard of care lung SABR treatment for the patient arm (for example, excessive tumor size, severe pulmonary fibrosis are relative contraindications for lung SABR and are part of standard of care clinical decision making). Patients with newly-developed pneumothorax Patients with critical acute illness precluding SABR in the judgment of the treating physician (examples could include active pulmonary embolism and infection requiring inpatient care) Patients with ECOG Performance Status 4

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers<br>The healthy patient will execute the Percussive ventilation breathhold technique | Other: Percussive Ventilation Breathhold SABR (PVB-SABR)<br>* Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment<br>|
| Other: Administration of the PVB-SABR in lung cancer patients<br>Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan. | Other: Percussive Ventilation Breathhold SABR (PVB-SABR)<br>* Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate 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. | 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 3 months | 
| Questionnaire data on Hospital Anxiety and Depression for lung cancer patients | Questionnaires on Hospital Anxiety and Depression Scale (HADS) will be collected on an optional exploratory basis at baseline and after the study intervention. | at baseline, and at the time of mock simulation (3 months) | 
| Questionnaire data on patient anxiety for lung cancer patients | Questionnaires on Spielberger State Anxiety (STAI) will be collected on an optional exploratory basis at baseline and after the study intervention. | 8 weeks | 
| Qualitative assessment of the training materials for Healthy patients | qualitative questionnaire about the educational materials will be collected on an optional exploratory basis at baseline and after the study intervention. | During first education session (8 weeks), then at the time of mock simulation (3 months) | 
| Qualitative assessment of the training materials for lung cancer patients | qualitative questionnaire about the educational materials will be collected on an optional exploratory basis at baseline and after the study intervention. | 8 weeks | 
| Patient motivation to learn the technique from study educational materials for Healthy Patients | learner motivation from the educational materials (LMSS) will be collected on an optional exploratory basis at baseline and after the study intervention. | During first education session (8 weeks), then at the time of mock simulation (3 months) | 
| Patient motivation to learn the technique from study educational materials for lung cancer patients | learner motivation from the educational materials (IMSS) will be collected on an optional exploratory basis at baseline and after the study intervention. | 8 weeks | 
| Additional time-related endpoints for duration of breathhold with Percussive Ventilation Breathhold (PVB) intervention for lung cancer patients | The rates will be measured as the proportion of patients who can execute a PV breathhold for both 5 and 10 minutes | 3 months | 
| Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold (PVB) | 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. | 3 months |