Skip to main content
OpenTrials
Completed

NCT Number: NCT05283564

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Cancer Institute

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Percussive Ventilation Breathhold SABR (PVB-SABR)

Other

Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    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).

  2. Exploratory clinical and dosimetric data on PVB and PVB-SABR technique

    Time frame: Perioperative/Periprocedural

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.