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PilotStudyAssessSafeActiveSurveillancApproachLocalThe Pa w/BrainMetsUndergoinCNSPenetratSystemicThe

13. september 2026 opdateret af: Aaron Benjamin Simon, University of California, Irvine

A Pilot Study Assessing the Safety of an Active Surveillance Approach to Local Therapy in Patients With Brain Metastases Undergoing CNS-Penetrating Systemic Therapy

This is a Pilot clinical trial determining the safety of an active surveillance approach to local therapy in subjects with brain metastases. These are subjects who are undergoing CNS-penetrating systemic therapy.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Anslået)

12

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Chao Family Comprehensive Cancer Center University of California, Irvine
  • Telefonnummer: 1-877-827-8839
  • E-mail: ucstudy@uci.edu

Undersøgelse Kontakt Backup

  • Navn: University of California Irvine Medical

Studiesteder

    • California
      • Orange, California, Forenede Stater, 92868
        • Rekruttering
        • Chao Family Comprehensive Cancer Center, University of California, Irvine
        • Kontakt:

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with brain metastases undergoing CNS-penetrating systemic therapy

Beskrivelse

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed metastatic non-hematologic malignancy.
  • Patients must have at least one new or progressive brain metastasis that has not received prior local therapy (surgery or radiation therapy).
  • Patients must have no active brain metastasis >3cm in size.
  • Leptomeningeal disease is permitted
  • Patients with only non-measurable disease as defined by the RANO-BM criteria are permitted so long as the clinical determination of new or progressive disease has been made by the treating team.
  • Patients must have no symptoms attributable to active brain metastases.
  • At the time of enrollment, patients must be eligible for AND planning to begin a new line of systemic therapy with potential for CNS-efficacy. Determination of potential for CNS-efficacy will be determined based on the clinical judgement of the treating physicians. Patients must have had no prior exposure to the specific systemic therapy in question at the time of enrollment, though exposure to other medications from a similar class are acceptable at the discretion of the treating team.
  • Patient must be planning to defer radiation therapy to trial medical therapy regardless of enrollment on trial.
  • Must be age ≥ 18 years.
  • Patients must be willing to complete MoCA and FACT-BR assessments (refer to section 4.4.1).
  • Performance status: KPS performance status ≥50%.
  • Life expectancy of ≥3 months.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have only progressive growth of brain lesions that have previously been treated with surgery or radiation therapy.
  • Patients with active symptomatic brain metastases.
  • Patients requiring corticosteroids, anticonvulsants, or other palliative medications related to brain metastases.
  • Patients with conditions that exclude them from undergoing magnetic resonance imaging.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
SingleArm
CNS-Penetrating Systemic Therapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of Enrolling Patients
Tidsramme: 1 year
Feasibility of enrolling patients as measured by percentage of patients enrolled compared to the anticipated study accrual.
1 year
Feasibility of completing required surveillance imaging
Tidsramme: 1 year
Feasibility of completing required surveillance imaging as measured by percentage of enrolled patients that complete surveillance imaging.
1 year
Feasibility of administering Cognitive Assessments
Tidsramme: 1 year
Feasibility of completing required Cognitive Assessments as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
1 year
Feasibility of administering QOL Questionnaires
Tidsramme: 1 year
Feasibility of completing required Quality of Life (QOL) Questionnaires as measured by percentage of enrolled patients that complete QOL and Cognitive Assessments..
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of pre-defined safety events
Tidsramme: 1 year
Number of subjects who experience incidence of pre-defined safety events associated with progression of intracranial disease while on systemic therapy
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Aaron Simon, MD, Chao Family Comprehensive Cancer Center

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)

4. august 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

2. september 2026

Først indsendt, der opfyldte QC-kriterier

13. september 2026

Først opslået (Faktiske)

18. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STUDY00001311
  • UCI 25-197 (Anden identifikator: UCI CFCCC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD will only be shared as a condition for publication of study results in ICMJE journals

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 .

Abonner