1. A Pilot Study to Evaluate Percussive Ventilation Breath Hold to Improve Lung Stereotactic Ablative Radiotherapy (PVB-SABR).
- Author
-
Mai, W.X., Swamy, A., Flores, K.Z., Langer, J., Free, D., Gebeyehu, P., Skinner, L., Wong, S., Huang, K.Z., Pranoto, A., Lao, O., Loo, B.W., and Blomain, E.
- Subjects
- *
STEREOTACTIC radiotherapy , *LUNG volume measurements , *LUNG cancer , *XEROSTOMIA , *CANCER patients - Abstract
Stereotactic ablative radiotherapy (SABR) effectively treats early-stage lung cancer, but tumor motion poses accuracy challenges. Inspiratory breath hold is an established strategy to mitigate lung motion, but its practicality is limited, especially in patients with reduced lung capacity. Percussive ventilation breath hold (PVB) is an innovative, non-invasive respiratory technique designed to maintain breathing function with minimal chest motion, thus eliminating motion uncertainty and improving treatment safety. This pilot study marks the first attempt to apply the novel physiology of PVB to lung SABR treatments. The primary objectives include determining the success rate of administering PVB for 5 minutes in healthy volunteers (Arm 1) and evaluating the success rate of PVB-SABR in lung cancer patients (Arm 2). Secondary objectives involve examining time-related endpoints for breath hold duration and assessing dosimetric benefits of PVB. This interim analysis includes 10 healthy volunteers and 1 patient enrolled between 1/2023 - 7/2023 (IRB 63842). Any person age 18 or older who would be deemed clinically eligible to undergo lung SABR treatment qualified to participate. Patients in Arm 2 require a diagnosis of primary lung cancer or lung metastasis. PVB is administered with Percussionaire IPV-2C. Participants either underwent mock simulation with PVB (Arm 1) or PVB-SABR treatment (Arm 2). CO2 levels were monitored transcutaneously (Sentec), and adverse effects were recorded according to CTCAE v5. Arm 1, involving healthy volunteers, has been completed. 9 of 10 volunteers (90%) tolerated PVB for at least 5 minutes, with 3 of 10 (30%) maintaining a 10-minute breath hold. The average PVB duration was 7.32 minutes (range: 2.5 – 14.17 mins). CO2 levels increased significantly after 5 minutes of PVB (p = 0.002), indicating a correlation between PVB duration and CO2 levels. Minimal adverse events were documented, with dry mouth being the most notable (40%). All adverse events resolved within 24 hours. In addition, subjects demonstrated the ability to repeat multiple, sequential breath holds using the PVB technique. The first patient in Arm 2 has successfully been treated with PVB-SABR. They were able to maintain PVB for 10 minutes. There were no long-term adverse events. This interim analysis on the first study evaluating use of PVB-SABR indicates a high tolerance for PVB with minimal adverse effects. Duration of successful PVB correlated with CO2 levels. These findings underscore PVB's potential as a safe, effective approach to lung SABR motion management. Treatment arm completion is expected by mid-2024. Future dosimetric analysis may demonstrate potential target sparing benefits with use of PVB. Notably, we've acquired the Monsoon III, a new ventilator device with improved patient tolerability and gas exchange. To this end, we have included an additional 5 healthy volunteers and will utilize Monsoon III for future PVB-SABR treatments. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF