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.
Age ≥ 18 years at the time of consent.
Participant is deemed clinically appropriate for standard-of-care proton therapy by treating radiation oncologist and will not require anesthesia for therapy.
Ability to understand and the willingness to sign a written informed consent document.
Participant has contraindications to proton therapy (per standard clinical guidelines).
Participant is unable to comply with routine treatment workflow or follow-up.
Participants who will be treated with a radiation plan of 5 fractions or fewer.
Single group
Treatment Planning Software
DeviceUniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.
Proportion 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.
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.
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.
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.
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.
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