Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radioth… (NCT05283564) | Clinical Trial Compass
RecruitingNot Applicable
Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy
United States20 participantsStarted 2022-11-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
What they're measuring
1
Rate of successful Percussive Ventilation Breathhold (PVB) maneuver in healthy volunteers.
Timeframe: 18 months
2
Rate of successful administration of Percussive Ventilation Breathhold Stereotactic Ablative Radiotherapy (PVB SABR) in lung patients.