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

NCT05283564 | Recruiting

• 2 other identifiers: IRB-63842NCI-2023-00704
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  18 months

Secondary Outcomes (2)

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

  3 months

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

  3 months

Study Arms (2)

Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers

OTHER

The healthy patient will execute the Percussive ventilation breathhold technique

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.

Other: Percussive Ventilation Breathhold SABR (PVB-SABR)

Interventions

Percussive Ventilation Breathhold SABR (PVB-SABR) OTHER

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

Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers; Administration of the PVB-SABR in lung cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Cancer Institute

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Wilson X Mai, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Huang

CONTACT

650-724-4606; kelhuang@stanford.edu

Anoushka Kathiravan

CONTACT

650-725-4796; akathir@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 17, 2022
• Study Start: November 2, 2022
• Primary Completion: May 4, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

US (1)