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

Stanford University

Status: Enrolling

Conditions: Lung Cancer

Treatments: Other: Percussive Ventilation Breathhold SABR (PVB-SABR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05283564

NCI-2023-00704 (Registry Identifier)

IRB-63842

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

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

Other group

Description:

The healthy patient will execute the Percussive ventilation breathhold technique

Treatment:

Other: Percussive Ventilation Breathhold SABR (PVB-SABR)

Administration of the PVB-SABR in lung cancer patients

Other group

Description:

Lung cancer patients will execute a PV breathhold and a verification cone-beam CT scan.

Treatment:

Other: Percussive Ventilation Breathhold SABR (PVB-SABR)