Title
Clinical Evaluation of a Treatment Planning Software and Oncology Information System for 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) approved by the U.S. Food and Drug Administration (FDA).

Objective
Primary:
- 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:
- To evaluate the treating physicianreported 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 AEs and device deficiencies related to the investigational RayTracker/RayAdaptive software.

Treatment The study intervention is the uniform application of the non-FDA approved 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 non-FDA approved 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 deemed clinically appropriate for standard-of-care proton therapy by their treating radiation oncologist.

Key Eligibility Inclusion Criteria
- Age > 18 years at the time of consent.
- Patient is deemed clinically appropriate for standard-of-care proton therapy by their treating radiation oncologist and will not require anesthesia for therapy.
- Ability to understand and the willingness to sign a written informed consent document.

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; Kidney; Leukemia; 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