Clinical Evaluation of a Treatment Planning Software and Oncology Information System for Proton Therapy
6. august 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
180
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Cancer Connect
- Telefonnummer: 800-622-8922
- E-post: clinicaltrials@cancer.wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- Rekruttering
- University of Wisconsin Hospital and Clinics (Carbone Cancer Center)
-
Ta kontakt med:
- UWCCC Cancer Connect
- Telefonnummer: 1-800-622-8922
- E-post: clinicaltrials@cancer.wisc.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment Planning Software
|
Uniform application of RayTracker and RayAdaptive software analyses for every verification image taken during proton therapy.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Benjamin Durkee, MD, PhD, University of Wisconsin, Madison
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. juli 2026
Primær fullføring (Antatt)
1. september 2027
Studiet fullført (Antatt)
1. september 2027
Datoer for studieregistrering
Først innsendt
6. august 2026
Først innsendt som oppfylte QC-kriteriene
6. august 2026
Først lagt ut (Faktiske)
12. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2026-0895
- Protocol Version 3/12/26 (Annen identifikator: UW Madison)
- UW26028 (Annen identifikator: UW Madison)
- UWMSN | SMPH | Radiation Medic (Annen identifikator: UW Madison)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .