Clinical trial NCT05283564: Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy
Official title: A Pilot Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.
timeFrame: 18 months
measure: Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) in lung patients.
timeFrame: 18 months
Secondary outcomes:
measure: Additional time-related endpoints for duration of breathhold with Percussive Ventilation (PV) breathhold intervention for Healthy patients
timeFrame: 3 months
measure: Exploratory clinical and dosimetric data on Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) technique
timeFrame: 3 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
Study officials:
affiliation: Stanford University
name: Wilson X Mai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: