An interventional study of Percussive Ventilation Breathhold SABR (PVB-SABR) in Lung Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Stanford University · Not applicable, Interventional, and Supportive care
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)
Secondary Objective(s)
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 25 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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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 Individuals. All individuals 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, individuals 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
The healthy patient will execute the Percussive ventilation breathhold technique
Other: Percussive Ventilation Breathhold SABR (PVB-SABR)
Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan.
Other: Percussive Ventilation Breathhold SABR (PVB-SABR)
Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment
The rate of successful Percussive Ventilation (PV) breathhold maneuver in healthy volunteers.
The rate will be measured as the proportion of healthy volunteers who can be successfully execute the PV 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: Day 1 (at Mock simulation visit)
The rate of successful administration of Percussive Ventilation Breathhold (PVB) Stereotactic Ablative Radiotherapy (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 SABR dose being delivered using the 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: Perioperative/Periprocedural
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 (Arm 1), as well as the proportion of patients who can execute a PV breathhold for both 5 and 10 minutes (Arm 2).
Time frame: Day 1 (during mock simulation visit for Arm 1 and simulation visit for Arm 2)
Exploratory clinical and dosimetric data on PVB and PVB-SABR technique
For Arm 1, during treatment planning, radiation plans will be generated using conventional SABR techniques as well as with PVB technique which will enable collection of exploratory dosimetric data such as tumor volume treated, volume and dose to healthy lung irradiated, dose to nearby normal structures and related measures, as well as the reproducibility of sequential breathholds. For both arms, 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: Perioperative/Periprocedural
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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