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

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Other: Percussive Ventilation Breathhold SABR (PVB-SABR)

• Registration Number: NCT05283564
• Lead Sponsor: Stanford University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-17
• Study Start: 2022-11-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-05-04
• Study Completion: 2025-05-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

Arm 1: No Pregnant Women. All women 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, women 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Administration of Percussive ventilation breathhold (PVB) technique in healthy volunteers	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	Percussive Ventilation Breathhold SABR (PVB-SABR)	Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan.

Primary Outcome Measures

Name	Time	Method
Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.	18 months	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.
Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) in lung patients.	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients	3 months	The rates will be measured as the proportion of healthy volunteers who can be successfully execute the PV breathhold for 10 minutes
Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique	3 months	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.

Trial Locations

Locations (1)

Stanford Cancer Institute; 🇺🇸 Palo Alto, California, United States