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NCT Number: NCT07759999

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

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.

Recruiting

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Key information

Conditions

Proton Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital and Clinics (Carbone Cancer Center)

Madison, Wisconsin, 53792, United States

Location status: Recruiting

Location contact

UWCCC Cancer Connect

CONTACT

[email protected]

1-800-622-8922

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment Planning Software

Device

Uniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.

Primary outcomes

  1. Proportion of verification image assessments resulting in an adaptive replanning decision

    Time frame: 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 outcomes

  1. Concordance of RayAdaptive-predicted inadequate target coverage with repeat CT simulation findings

    Time frame: 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.

  2. Number of software-related adverse events and device deficiencies

    Time frame: 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.

  3. Proportion of adaptive replanning decisions influenced by RayTracker/RayAdaptive

    Time frame: 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.

  4. Concordance of RayAdaptive-predicted organ-at-risk dose constraint violations with repeat CT simulation findings

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Connect

CONTACT

[email protected]

800-622-8922

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

UW26028: Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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