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

Overview

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.

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.

Eligibility

Inclusion Criteria:

Arm 1: Healthy volunteers age 18 or older

        Arm 1: Ability to understand and the willingness to sign (personally or by a legal
        authorized representative) the written IRB approved informed consent document.
        Arm 2: Patients with a diagnosis of primary lung cancer or lung metastases of any primary
        tumor origin
        Arm 2: Patients deemed clinically eligible to be treated with standard of care lung SABR
        for patient arm
        Arm 2: Patients of any gender age 18 or older
        Arm 2: Patients with ECOG Performance Status 0-2 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
        Arm 2: Ability to understand and the willingness to sign (personally or by a legal
        authorized representative) the written IRB approved informed consent document.
        Exclusion Criteria:
        Arm 1: No Pregnant Women. All women of child bearing potential (last menstrual period
        within the previous 12 months and not surgically sterile) will be tested for pregnancy and
        documented by study team.
        Arm 2: Patients clinically deemed ineligible for standard of care lung SABR treatment for
        the patient arm (for example, excessive tumor size, women who are pregnant or breast
        feeding, severe pulmonary fibrosis are relative contraindications for lung SABR and are
        part of standard of care clinical decision making).
        Arm 2: Patients with newly-developed pneumothorax
        Arm 2: 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)
        Arm 2: Patients with ECOG Performance Status 4