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Brain Connectivity Changes in Glioma Patients During Treatment (GliRecon)

28. maj 2026 opdateret af: Michael Sonnberger, Johannes Kepler University of Linz

Functional Reorganization and Connectivity in Glioma Patients During the Therapeutic Trajectory

The goal of this observational study is to better understand how the brain changes during the treatment of glioma. In particular, the study looks at changes in important brain areas that are responsible for functions such as movement, language, or sensation, as well as the nerve fiber pathways that connect these areas.

The main question this study aims to answer is:

How do important brain areas and their connections adapt and reorganize over the course of glioma treatment?

Patients with glioma will undergo repeated brain imaging examinations as part of their regular medical care. These images will be analyzed over time to observe changes in brain activity and structure during different stages of therapy.

By studying these changes, researchers hope to gain new insights into the brain's ability to adapt (neuroplasticity) throughout the entire course of glioma treatment.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

20

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Østrig
    • Upper Austria
      • Linz, Upper Austria, Østrig, 4020
        • Rekruttering
        • Kepler University Hospital

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

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults with diffuse gliomas (WHO grade 2-4) undergoing multimodal treatment and eligible for functional MRI and neurocognitive assessment.

Beskrivelse

Inclusion Criteria:

  • Patients with diffuse gliomas (WHO grade 2-4).
  • Age >18 years and <65 years.
  • Written participant information and informed consent provided and signed.
  • Signed informed consent for functional magnetic resonance imaging (fMRI).

Exclusion Criteria:

  • Age <18 years or >65 years.
  • Pregnancy.

  • Contraindications to MRI, including but not limited to:

    • Active medical implants (e.g., pain pump, defibrillator, cardiac pacemaker),
    • Orthodontic braces,
    • Metallic tattoos,
    • Non-removable piercings,
    • Known metallic foreign bodies,
    • Claustrophobia.
  • Cerebral metastases from secondary (non-primary) tumors.
  • Absence of baseline BOLD functional MRI and/or baseline neurocognitive assessment.
  • Failure to provide written participant information and informed consent.
  • Karnofsky Performance Status (KPS) <60, unless feasibility of clinical-psychological testing and BOLD fMRI is confirmed by the investigator in consultation with clinical psychology, radiology staff, and the patient.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment-related changes in BOLD signal and diffusion tensor imaging (DTI) outcomes across different stages of treatment.
Tidsramme: Day 0 (pre-neurosurgery baseline), Day 28 (post-surgery/pre-radiotherapy), and Day 126 to Day 140 (post-treatment)
This outcome assesses changes from baseline in neurofunctional activation measured by blood-oxygen-level-dependent (BOLD) functional MRI and in brain microstructural properties measured by diffusion tensor imaging (DTI) parameters (e.g., fractional anisotropy and mean diffusivity) at predefined time points during treatment. Not all participants will undergo radiotherapy as part of standard clinical care; therefore, the timing of the final assessment corresponds to the respective treatment stage.
Day 0 (pre-neurosurgery baseline), Day 28 (post-surgery/pre-radiotherapy), and Day 126 to Day 140 (post-treatment)
Treatment-related changes in neurofunctional activation patterns and cerebral organizational and reorganization processes assessed by functional MRI and diffusion tensor imaging (DTI) at 1-year follow-up from treatment initiation.
Tidsramme: Day 0 (pre-neurosurgery baseline) and Day 365 (one-year follow-up)
This outcome assesses changes from baseline in neurofunctional activation measured by blood-oxygen-level-dependent (BOLD) functional MRI and in brain microstructural properties measured by diffusion tensor imaging (DTI) parameters (e.g., fractional anisotropy and mean diffusivity) at the one-year follow-up compared with measurements obtained at the start of treatment.
Day 0 (pre-neurosurgery baseline) and Day 365 (one-year follow-up)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BOLD functional MRI signal change
Tidsramme: Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Brain activation measured as blood oxygen level-dependent (BOLD) signal change using functional MRI during task-based acquisition.
Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Fractional anisotropy (DTI)
Tidsramme: Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Fractional anisotropy values derived from diffusion tensor imaging (DTI) assessed during treatment and follow-up.
Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Mean diffusivity (DTI)
Tidsramme: Day 0, Day 126-140, Day 365
Mean diffusivity values derived from diffusion tensor imaging (DTI).
Day 0, Day 126-140, Day 365
Cognitive performance score
Tidsramme: 0, Day 126-140, Day 365
Cognitive performance assessed using standardized neuropsychological test scores.
0, Day 126-140, Day 365
Patient-reported quality of life score
Tidsramme: Day 0, Day 126-140, Day 365
Patient-reported quality of life measured using validated questionnaires.
Day 0, Day 126-140, Day 365

Samarbejdspartnere og efterforskere

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

Sponsor

Johannes Kepler University of Linz

Samarbejdspartnere

Clinical Research Institute for Neurosciences, JKU Linz, Austria
Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Lin
Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University Linz
Department of Radiation Oncology, Ordensklinikum Linz, Barmherzige Schwestern, Linz, Austria

Efterforskere

  • Studiestol: Raimund Kleiser, PD Dr., Neuroimaging Sciences and Support Center ,Clinical Institute for Neurosciences, Institute of Neuroradiology, Kepler Unisversity Hospital Linz, Johannes Kepler University
  • Studiestol: Andreas Gruber, Full Professor, Head of Clinical Institute for Neurosciences, Head of the Departmend of Neurosurgery, Kepler Unisversity Hospital Linz, Johannes Kepler University
  • Studiestol: Hans Geinitz, Professor, Head of Department of Radiation Oncology, Clinical Institute for Neurosciences
  • Ledende efterforsker: Michael Sonnberger, MD, Head of Institute of Neuroradiology, Kepler University Hospital Linz, Johannes Kepler University

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 (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. september 2029

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1419/2025

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