Clinical Study of RayStation 2025 and RayCare 2025 Software for Supporting Standard Proton Therapy Treatment

What this Trial Is About

Researchers are evaluating how well upgraded treatment planning and clinical workflow software systems support the delivery of standard-of-care proton radiation therapy. This study focuses on patients who are clinically appropriate for proton therapy as determined by their radiation oncologist. It aims to assess the clinical use and safety of RayStation 2025 and RayCare 2025 software during proton therapy treatment. Participants will receive standard proton therapy supported by the RayTracker and RayAdaptive software, which analyze verification images taken throughout treatment. The study monitors how the software influences adaptive replanning decisions and checks for any software-related adverse events or device deficiencies. This evaluation occurs from the first verification image through the completion of proton therapy, lasting up to 22 weeks, with additional safety follow-up for 90 days after treatment. During the study, participants will undergo regular verification imaging and clinical assessments to monitor treatment progress and software performance. Researchers will measure the proportion of verification images that lead to adaptive treatment changes, assess software prediction accuracy compared to repeat CT scans, and track any adverse events related to the software. Participation involves adherence to routine treatment workflow and follow-up over the course of proton therapy and the post-treatment safety period, with total involvement lasting up to several months.

Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy