Lung Cancer Clinical Trial
Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy
Summary
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.
Full Description
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
Eligibility Criteria
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
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