Magnetic Resonance-Guided Stereotactic Body Radiation Therapy for the Treatment of Metastatic Solid Tumors, ONE SHOT Trial
20. august 2026 oppdatert av: Jonsson Comprehensive Cancer Center
ONE SHOT: Single-Fraction Adaptive MR-Guided Radiation Therapy for Metastatic Solid Tumors
This clinical trial studies the side effects of magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) and to see how well it works in treating patients with solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic).
SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body.
The total dose of radiation is divided into smaller doses given over 1-5 days.
This type of radiation therapy helps spare normal tissue.
During MR-guided SBRT, MR imaging is used to define and localize the area to be treated and provide more accurate delivery.
This allows the treatment to be given over one day.
MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors.
Tumors in the central nervous system will not be treated on this study.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
PRIMARY OBJECTIVE:
I. To evaluate the incidence of acute grade ≥ 3 adverse events that are possibly, probably, or definitely related to single-fraction adaptive MR-guided SBRT.
SECONDARY OBJECTIVES:
I. To estimate local control (LC), progression-free survival (PFS) and overall survival (OS).
II. To characterize late grade ≥ 3 toxicity rates per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
III. To assess patient-reported health-related quality of life (HRQOL) using Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) at baseline, end of treatment, 3 months post-treatment, and 1 year post-treatment.
IV. To measure total in-room time, defined as the duration from patient entry to exit at the treatment console.
OUTLINE:
Patients undergo MR-guided SBRT over one treatment fraction on study. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) on study and CT or PET/CT throughout the study.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
Studietype
Intervensjonell
Registrering (Antatt)
25
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: Carol Felix
- Telefonnummer: 310-825-9771
- E-post: cfelix@mednet.ucla.edu
Studer Kontakt Backup
- Navn: Christy Palodichuk
- Telefonnummer: 1 310-794-2971
- E-post: cpalodichuk@mednet.ucla.edu
Studiesteder
-
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California
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Los Angeles, California, Forente stater, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Ta kontakt med:
- Christy Palodichuk
- Telefonnummer: 310-794-2971
- E-post: cpalodichuk@mednet.ucla.edu
-
Ta kontakt med:
- Care Felix
- Telefonnummer: +1 310-825-9771
- E-post: cfelix@mednet.ucla.edu
-
Hovedetterforsker:
- Ann Raldow, MD
-
-
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
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Histologically confirmed metastatic solid tumor (any primary site)
- 1-3 metastases ≤ 5 cm each located outside the brain and spine
- Lesions treatable at 25-30 Gy × 1 fraction with MR guidance
- No overlapping prior radiation
- Absolute neutrophil count (ANC) > 1.5 cell/mm^3
- Hemoglobin (Hgb) > 8.0 gm/dL
- Platelet (PLT) > 150,000/mm^3
- Total bilirubin < or equal to 1.5 x upper limit of normal
- Aspartate aminotransferase (AST) < or equal to three times upper limit of normal
- Alanine aminotransferase (ALT) < or equal to three times upper limit of normal
- Informed consent obtained
Exclusion Criteria:
- Uncontrolled infection or major comorbidity
- Pregnant or breastfeeding
- MRI contraindication
- Life expectancy < 3 months
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment (MR-guided SBRT)
Patients undergo MR-guided SBRT over one treatment fraction on study.
Patients also undergo MRI and CT on study and CT or PET/CT throughout the study.
|
Hjelpestudier
Gjennomgå MR
Andre navn:
Gjennomgå PET/CT
Andre navn:
Gjennomgå CT og/eller PET/CT
Andre navn:
Undergo MR-guided SBRT
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acute toxicity rate
Tidsramme: Up to 3 months post-radiation therapy
|
Defined as the percentage of patients who experience acute grade ≥ 3 adverse events relating to single-fraction adaptive magnetic resonance-guided stereotactic body radiation therapy.
Will be calculated, along with the corresponding 95% Clopper-Pearson exact confidence interval.
Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
|
Up to 3 months post-radiation therapy
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to local failure (Local control)
Tidsramme: From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months
|
As assessed by imaging and clinical evaluation, according to Response Evaluation Criteria in Solid Tumors version 1.1.
Will be estimated via Kaplan-Meier (KM) analysis.
The median survival along with 95% confidence interval will also be reported.
|
From end of study treatment to the presence of local or locoregional disease progression within the irradiated field, assessed up to 12 months
|
|
Progression-free survival
Tidsramme: From end of study treatment to the first documented evidence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months
|
Will be estimated via KM analysis.
The median survival along with 95% confidence interval will also be reported.
|
From end of study treatment to the first documented evidence of disease progression or death from any cause, whichever occurs first, assessed up to 12 months
|
|
Overall survival
Tidsramme: From end of study treatment to death from any cause, assessed up to 12 months
|
Will be estimated via KM analysis.
The median survival along with 95% confidence interval will also be reported.
|
From end of study treatment to death from any cause, assessed up to 12 months
|
|
Incidence of late grade ≥ 3 toxicities
Tidsramme: From 3 months post-radiation therapy up to 12 months post-radiation therapy
|
Assessed per CTCAE v5.0 for entire and sub-cohort, stratified by anatomic treatment site.
Will be characterized via descriptive statistics.
|
From 3 months post-radiation therapy up to 12 months post-radiation therapy
|
|
PROMIS-29 patient-reported health-related quality-of-life (HRQOL)
Tidsramme: Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment
|
Assessed using PROMIS-29 HRQOL questionnaires (Patient-Reported Outcomes Measurement Information System 29-item profile).
Raw domain scores are converted to T-scores calibrated to the US general population, with a mean of 50 and standard deviation of 10.
For symptom domains (anxiety, depression, fatigue, pain interference, sleep disturbance), higher scores indicate worse symptom burden.
For functioning domains (physical function, social participation), higher scores indicate better functioning.
Changes from baseline to 3 time points post-treatment will be analyzed.
|
Peritreatment/Periprocedural, 3 months post-treatment, and 12 months post-treatment
|
|
Total in-room time
Tidsramme: From patient entry to exit at the treatment console, approximately one day
|
The duration from patient entry to exit at the treatment console will be collected; summary statistics will be reported for entire cohort and sub-cohort of treated target number 1, 2 and 3, respectively.
|
From patient entry to exit at the treatment console, approximately one day
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ann Raldow, MD, UCLA / Jonsson Comprehensive Cancer Center
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 (Antatt)
1. desember 2026
Primær fullføring (Antatt)
1. desember 2036
Studiet fullført (Antatt)
1. desember 2038
Datoer for studieregistrering
Først innsendt
16. juni 2026
Først innsendt som oppfylte QC-kriteriene
23. juni 2026
Først lagt ut (Faktiske)
26. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-0235
- NCI-2026-04081 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
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
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