Researchers are doing this study to better understand how certain treatment planning and clinical workflow software systems support the delivery of standard-of-care proton radiation therapy. The main question it aims to answer is how well the software works in the workflow. Participants will receive proton therapy.
This study is being done to evaluate the clinical utilization and safety of RayStation 2025 and RayCare 2025 treatment planning software upgrades when used to support standard-of-care proton therapy delivery in patients deemed clinically appropriate for such therapy by their treating radiation oncologist.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
180
Uniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.
University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
Madison, Wisconsin, United States
RECRUITINGProportion of verification image assessments resulting in an adaptive replanning decision
Proportion of evaluable verification image assessments that result in an order for repeat CT simulation and/or treatment plan reoptimization. Each verification image assessment is classified as resulting or not resulting in an adaptive replanning decision.
Time frame: From the first verification image assessment through completion of proton therapy, up to 22 weeks
Concordance of RayAdaptive-predicted inadequate target coverage with repeat CT simulation findings
Agreement between the binary RayAdaptive prediction of inadequate target coverage (Yes/No) and the binary determination on repeat CT simulation (confirmed/not confirmed), among assessments for which repeat CT simulation is obtained. Inadequate target coverage is defined as failure to meet prescribed dose and target coverage constraints.
Time frame: From the first verification image assessment through completion of proton therapy, up to 22 weeks
Number of software-related adverse events and device deficiencies
Number of adverse events and device deficiencies assessed as at least possibly related to the investigational RayTracker/RayAdaptive software or its incorporation into the clinical workflow. Events and deficiencies will be summarized by type, severity or grade, and attribution.
Time frame: During proton therapy and through 90 days after completion of proton therapy
Proportion of adaptive replanning decisions influenced by RayTracker/RayAdaptive
Proportion of adaptive replanning decisions for which the treating physician reports that RayTracker/RayAdaptive influenced clinical decision-making, recorded as Yes/No using the standardized treating physician assessment.
Time frame: From the first verification image assessment through completion of proton therapy, up to 22 weeks
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Concordance of RayAdaptive-predicted organ-at-risk dose constraint violations with repeat CT simulation findings
Agreement between the binary RayAdaptive prediction of a potential organ-at-risk dose constraint violation (Yes/No) and the binary determination on repeat CT simulation (confirmed/not confirmed), among assessments for which repeat CT simulation is obtained.
Time frame: From the first verification image assessment through completion of proton therapy, up to 22 weeks