Proton Therapy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICETreatment Planning Software
Uniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of verification image assessments resulting in an adaptive replanning decision | From the first verification image assessment through completion of proton therapy, up to 22 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of RayAdaptive-predicted inadequate target coverage with repeat CT simulation findings | From the first verification image assessment through completion of proton therapy, up to 22 weeks | 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 | During proton therapy and through 90 days after completion of proton therapy | 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 | From the first verification image assessment through completion of proton therapy, up to 22 weeks | 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 | From the first verification image assessment through completion of proton therapy, up to 22 weeks | 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. |
Countries
United States
Contacts
CONTACTCancer Connect
PRINCIPAL_INVESTIGATORBenjamin Durkee, MD, PhD
University of Wisconsin, Madison
Outcome results
None listed