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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Percussive Ventilation Breathhold SABR (PVB-SABR)

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.
• To collect patient-reported data on hospital-associated anxiety, motivation to learn the technique from the educational materials, and subjective evaluation of those materials

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aneesh Swamy; Phone Number: 650-725-2084; Email: arswamy@stanford.edu
• Study Contact Backup: Name: Kevin Flores; Phone Number: 650-725-4796; Email: kevinflo@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford Cancer Institute
      • Contact: Aneesh Swamy; Phone Number: 650-725-2084; Email: arswamy@stanford.edu
      • Contact: Kevin Flores; Phone Number: 650-725-4796; Email: kevinflo@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy volunteers age 18 or older
• Patients with a diagnosis of primary lung cancer or lung metastases of any primary tumor origin
• Patients deemed clinically eligible to be treated with standard of care lung SABR for patient arm
• Patients of any gender age 18 or older
• Patients with ECOG Performance Status 1-2 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

Exclusion Criteria:

• No Pregnant Women
• Patients clinically deemed ineligible for standard of care lung SABR treatment for the patient arm (for example, excessive tumor size, severe pulmonary fibrosis are relative contraindications for lung SABR and are part of standard of care clinical decision making).
• Patients with newly-developed pneumothorax
• 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)
• Patients with ECOG Performance Status 4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers; The healthy patient will execute the Percussive ventilation breathhold technique	Other: Percussive Ventilation Breathhold SABR (PVB-SABR); Number of lung cancer patients with successful administration of PVB technique in PVB-SABR treatment
Other: Administration of the PVB-SABR in lung cancer patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months
Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique	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.	3 months
Questionnaire data on Hospital Anxiety and Depression for lung cancer patients	Questionnaires on Hospital Anxiety and Depression Scale (HADS) will be collected on an optional exploratory basis at baseline and after the study intervention.	at baseline, and at the time of mock simulation (3 months)
Questionnaire data on patient anxiety for lung cancer patients	Questionnaires on Spielberger State Anxiety (STAI) will be collected on an optional exploratory basis at baseline and after the study intervention.	8 weeks
Qualitative assessment of the training materials for Healthy patients	qualitative questionnaire about the educational materials will be collected on an optional exploratory basis at baseline and after the study intervention.	During first education session (8 weeks), then at the time of mock simulation (3 months)
Qualitative assessment of the training materials for lung cancer patients	qualitative questionnaire about the educational materials will be collected on an optional exploratory basis at baseline and after the study intervention.	8 weeks
Patient motivation to learn the technique from study educational materials for Healthy Patients	learner motivation from the educational materials (LMSS) will be collected on an optional exploratory basis at baseline and after the study intervention.	During first education session (8 weeks), then at the time of mock simulation (3 months)
Patient motivation to learn the technique from study educational materials for lung cancer patients	learner motivation from the educational materials (IMSS) will be collected on an optional exploratory basis at baseline and after the study intervention.	8 weeks
Additional time-related endpoints for duration of breathhold with Percussive Ventilation Breathhold (PVB) intervention for lung cancer patients	The rates will be measured as the proportion of patients who can execute a PV breathhold for both 5 and 10 minutes	3 months
Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold (PVB)	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.	3 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Erik Blomain, MD, PHD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Estimated): May 2, 2024
• Study Completion (Estimated): May 2, 2024

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB-63842

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No