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

Description
This is a nonrandomized, single arm, open-label, prospective interventional trial to determine the rate of adaptive replanning for proton therapy when RayTracker and RayAdaptive are used as decision-support tools in the analysis of every verification image obtained during each subject’s proton therapy treatment course. This study will evaluate, under a defined prospective clinical research framework, the performance, reliability, usability, and clinical feasibility of implementing RayTracker and RayAdaptive – software components that have not yet been 510(k) cleared by the U.S. Food and Drug Administration (FDA).

Objective
Primary Objective
To determine the frequency of adaptive replanning during proton therapy when RayTracker and RayAdaptive are incorporated into routine verification image review as clinical decision-support tools.

Secondary Objectives
To evaluate the treating physician-reported rate at which RayTracker and RayAdaptive influenced the decision to pursue adaptive replanning during proton therapy.
To explore concordance between RayAdaptive-predicted inadequate target coverage on verification imaging and findings on repeat CT simulation when performed.
To explore concordance between RayAdaptive-predicted organ-at-risk dose constraint violations and findings on repeat CT simulation when performed.
To report the incidence of adverse events (AEs) and device deficiencies related to the investigational RayTracker/RayAdaptive software.

Treatment The study intervention is the uniform application of the not yet FDA-cleared RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy treatment for every subject enrolled in this study. This requires use of the not yet FDAcleared RayStation 2025 and RayCare 2025 Treatment Planning Software, which is an upgrade of the current FDA-cleared software. For all subjects enrolled on this protocol, this investigational software will be used during standard of care proton therapy in patients for whom proton therapy has already been recommended as part of routine clinical care, independent of this study. The software analyzes only standard-of-care verification imaging; the protocol mandates no additional imaging, radiation, anesthesia, or visit for research purposes.

Key Eligibility 1. Age ≤17 years at the time of consent/assent.
2. Patient has a clinical indication for radiation therapy, and the treating radiation oncologist has independently determined that proton therapy is clinically appropriate and has recommended proton therapy as part of the patient's routine clinical care, independent of participation in this research study. Proton therapy may be delivered with or without anesthesia when clinically indicated.
3. Written informed consent will be obtained from adult subjects or the parent/legal guardian of pediatric subjects. Assent will be obtained from pediatric participants when appropriate according to institutional policy.

Applicable Disease Sites
Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital