Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy
6. august 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
180
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Cancer Connect
- Telefonnummer: 800-622-8922
- E-mail: clinicaltrials@cancer.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792
- Rekruttering
- University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
-
Kontakt:
- UWCCC Cancer Connect
- Telefonnummer: 1-800-622-8922
- E-mail: clinicaltrials@cancer.wisc.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment Planning Software
|
Uniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of verification image assessments resulting in an adaptive replanning decision
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Concordance of RayAdaptive-predicted inadequate target coverage with repeat CT simulation findings
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Benjamin Durkee, MD, PhD, University of Wisconsin, Madison
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. juli 2026
Primær færdiggørelse (Anslået)
1. september 2027
Studieafslutning (Anslået)
1. september 2027
Datoer for studieregistrering
Først indsendt
6. august 2026
Først indsendt, der opfyldte QC-kriterier
6. august 2026
Først opslået (Faktiske)
12. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-0895
- Protocol Version 3/12/26 (Anden identifikator: UW Madison)
- UW26028 (Anden identifikator: UW Madison)
- UWMSN | SMPH | Radiation Medic (Anden identifikator: UW Madison)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .