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

NCT07759999 | Recruiting DMC FDA Device

• 4 other identifiers: 2026-0895UW26028Protocol Version 3/12/26UWMSN | SMPH | Radiation Medic
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Proton Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  From the first verification image assessment through completion of proton therapy, up to 22 weeks

Secondary Outcomes (4)

• 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

• Number of software-related adverse events and device deficiencies

  During proton therapy and through 90 days after completion of proton therapy

• Proportion of adaptive replanning decisions influenced by RayTracker/RayAdaptive

  From the first verification image assessment through completion of proton therapy, up to 22 weeks

• 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

Study Arms (1)

Treatment Planning Software

EXPERIMENTAL

Device: Treatment Planning Software

Interventions

Treatment Planning Software DEVICE

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

Treatment Planning Software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics (Carbone Cancer Center)

Madison, Wisconsin, 53792, United States

RECRUITING

Study Officials

• Benjamin Durkee, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 12, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

US (1)