Proton TherapyNCT07759999
Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy
A study testing Treatment Planning Software in people with Proton Therapy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proton Therapy
- What is being tested?
- Treatment Planning Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
Madison, Wisconsin, 53792
UWCCC Cancer Connect, 1-800-622-8922, clinicaltrials@cancer.wisc.edu
About this study
Official title: UW26028: 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.
Read the 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.
- Conditions
- Proton Therapy
- Being tested
- Treatment Planning Software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Planning SoftwareDevice
Uniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Planning Software | Experimental | Not described Receives: Device: Treatment Planning Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: From the first verification image assessment through completion of proton therapy, up to 22 weeks
Number of software-related adverse events and device deficiencies
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.
Measured: During proton therapy and through 90 days after completion of proton therapy
Proportion of adaptive replanning decisions influenced by RayTracker/RayAdaptive
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.
Measured: 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
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.
Measured: From the first verification image assessment through completion of proton therapy, up to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start15 Jul 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton TherapyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Durkee, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759999
- Sponsor's protocol ID
- 2026-0895
- Other IDs
- UW26028, Protocol Version 3/12/26, UWMSN | SMPH | Radiation Medic
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UW26028: Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy
- ClinicalTrials.gov ID
- NCT07759999
- Acronym / sponsor ID
- 2026-0895
- Conditions
- Proton Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Planning Software | Experimental | Device: Treatment Planning Software |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Planning SoftwareUniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy. | Device | Treatment Planning Software |
Primary outcome
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.
4 secondary outcomes
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
Number of software-related adverse events and device deficiencies
Time frame: During proton therapy and through 90 days after completion of proton therapy
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Durkee, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Planning Software in people with Proton Therapy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Connect (800-622-8922, clinicaltrials@cancer.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.