Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy
6 augusti 2026 uppdaterad av: University of Wisconsin, Madison
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
180
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Cancer Connect
- Telefonnummer: 800-622-8922
- E-post: clinicaltrials@cancer.wisc.edu
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- Rekrytering
- University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
-
Kontakt:
- UWCCC Cancer Connect
- Telefonnummer: 1-800-622-8922
- E-post: clinicaltrials@cancer.wisc.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment Planning Software
|
Uniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of verification image assessments resulting in an adaptive replanning decision
Tidsram: 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.
|
From the first verification image assessment through completion of proton therapy, up to 22 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Concordance of RayAdaptive-predicted inadequate target coverage with repeat CT simulation findings
Tidsram: 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.
|
From the first verification image assessment through completion of proton therapy, up to 22 weeks
|
|
Number of software-related adverse events and device deficiencies
Tidsram: 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.
|
During proton therapy and through 90 days after completion of proton therapy
|
|
Proportion of adaptive replanning decisions influenced by RayTracker/RayAdaptive
Tidsram: 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.
|
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
Tidsram: 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.
|
From the first verification image assessment through completion of proton therapy, up to 22 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Benjamin Durkee, MD, PhD, University of Wisconsin, Madison
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 juli 2026
Primärt slutförande (Beräknad)
1 september 2027
Avslutad studie (Beräknad)
1 september 2027
Studieregistreringsdatum
Först inskickad
6 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
6 augusti 2026
Första postat (Faktisk)
12 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2026-0895
- Protocol Version 3/12/26 (Annan identifierare: UW Madison)
- UW26028 (Annan identifierare: UW Madison)
- UWMSN | SMPH | Radiation Medic (Annan identifierare: UW Madison)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .