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

NCT ID: NCT05283564Sponsor: Stanford UniversityLast updated: 2025-07-15

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.

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.

Arms & interventions

  • OtherPercussive Ventilation Breathhold SABR (PVB-SABR)

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

Outcome measures

Primary

  • Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.

    The rate will be measured as the proportion of healthy volunteers who can be successfully execute the Percussive Ventilation 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: 18 months

  • Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB 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 Stereotactic Ablative Radiotherapy dose being delivered using the Percussive Ventilation Breathhold (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: 18 months

Secondary

  • Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients

    Time frame: 3 months

  • Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique

    Time frame: 3 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
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

Study locations (1)

Stanford Cancer Institute

Palo Alto, California, 94305

Recruiting
Kelly Huang · Contact
Anoushka Kathiravan · Contact
Wilson X Mai, MD,PhD · Principal Investigator
Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy | Cancerify