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

Launched by STANFORD UNIVERSITY · Mar 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new method called Percussive Ventilation Breathhold (PVB) to help improve the accuracy of radiation therapy for treating lung cancer. The goal is to see how well this technique works in making sure radiation is delivered precisely to lung tumors, which could lead to better treatment outcomes for patients.

To participate in this study, you must be at least 18 years old. If you are a healthy volunteer, you can join the first group. If you have lung cancer or lung metastases (cancer that has spread to the lungs), you may be eligible for the second group. Participants will need to understand and agree to the study rules, and they will be monitored throughout the process. It’s important to note that certain individuals, like pregnant women or those with specific serious health issues, may not be able to participate. Overall, this trial aims to find a better way to treat lung cancer, and your involvement could help advance this important research.

Gender

ALL

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