Status:
RECRUITING
Study to Evaluate Percussive Ventilation Breathhold to Improve Lung Stereotactic Ablative Radiotherapy
Lead Sponsor:
Stanford University
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 4 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05283564
Start Date
November 2 2022
End Date
September 4 2026
Last Update
July 15 2025
Active Locations (1)
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1
Stanford Cancer Institute
Palo Alto, California, United States, 94305