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Brain Connectivity Changes in Glioma Patients During Treatment (GliRecon)

11 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

20

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Österrike
    • Upper Austria
      • Linz, Upper Austria, Österrike, 4020
        • Rekrytering
        • Kepler University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment-related changes in BOLD signal and diffusion tensor imaging (DTI) outcomes across different stages of treatment.
Tidsram: 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.
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
BOLD functional MRI signal change
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: Day 0, Day 126-140, Day 365
Patient-reported quality of life measured using validated questionnaires.
Day 0, Day 126-140, Day 365

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Johannes Kepler University of Linz

Samarbetspartners

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

Utredare

  • 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
  • Huvudutredare: Michael Sonnberger, MD, Head of Institute of Neuroradiology, Kepler University Hospital Linz, Johannes Kepler University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

1 september 2029

Avslutad studie (Beräknad)

1 december 2029

Studieregistreringsdatum

Först inskickad

8 maj 2026

Först inskickad som uppfyllde QC-kriterierna

28 maj 2026

Första postat (Faktisk)

29 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1419/2025

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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