Lung CancerNCT05283564
Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy
A study testing Percussive Ventilation Breathhold SABR (PVB-SABR) in people with Lung Cancer, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Percussive Ventilation Breathhold SABR (PVB-SABR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2022to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Cancer Institute
Palo Alto, California, 94305
About this study
Official title: A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)
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.
Read the detailed 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.
- Conditions
- Lung Cancer
- Being tested
- Percussive Ventilation Breathhold SABR (PVB-SABR)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percussive Ventilation Breathhold SABR (PVB-SABR)Other
Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment
| Study group | Role | What they receive |
|---|---|---|
| Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers | Other | The healthy patient will execute the Percussive ventilation breathhold technique Receives: Other: Percussive Ventilation Breathhold SABR (PVB-SABR) |
| Administration of the PVB-SABR in lung cancer patients | Other | Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan. Receives: Other: Percussive Ventilation Breathhold SABR (PVB-SABR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Perioperative/Periprocedural
Secondary outcomes (2)
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).
Measured: 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.
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start2 Nov 2022
- Primary completion28 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Xuan Mai, Stanford University
- Investigators
- Wilson X Mai, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283564
- Sponsor's protocol ID
- IRB-63842
- Other IDs
- NCI-2023-00704
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2022
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)
- ClinicalTrials.gov ID
- NCT05283564
- Acronym / sponsor ID
- IRB-63842
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers | Other | Other: Percussive Ventilation Breathhold SABR (PVB-SABR)The healthy patient will execute the Percussive ventilation breathhold technique |
| Administration of the PVB-SABR in lung cancer patients | Other | Other: Percussive Ventilation Breathhold SABR (PVB-SABR)Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percussive Ventilation Breathhold SABR (PVB-SABR)Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment | Other | Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers, Administration of the PVB-SABR in lung cancer patients |
Primary outcome
The rate of successful Percussive Ventilation (PV) breathhold maneuver in healthy volunteers.
Time frame: Day 1 (at Mock simulation visit)
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.
The rate of successful administration of Percussive Ventilation Breathhold (PVB) Stereotactic Ablative Radiotherapy (SABR) in lung patients.
Time frame: Perioperative/Periprocedural
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.
2 secondary outcomes
Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients
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
Time frame: Perioperative/Periprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilson X Mai, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percussive Ventilation Breathhold SABR (PVB-SABR) in people with Lung Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful Percussive Ventilation (PV) breathhold maneuver in healthy volunteers. (time frame: Day 1 (at Mock simulation visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.