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Recruiting NCT07612917

Brain Connectivity Changes in Glioma Patients During Treatment

— Observational Glioma (Any Grade) in the Brain Gliomas, Malignant fMRI Research Neurocognitive Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Glioma (Any Grade) in the Brain, Gliomas, Malignant, fMRI Research, Neurocognitive Function. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Functional Reorganization and Connectivity in Glioma Patients During the Therapeutic Trajectory

Overview

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.

Primary outcome measures

  • Treatment-related changes in BOLD signal and diffusion tensor imaging (DTI) outcomes across different stages of treatment. [Time frame: 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. [Time frame: Day 0 (pre-neurosurgery baseline) and Day 365 (one-year follow-up)]
Secondary outcome measures (5)
  • BOLD functional MRI signal change [Time frame: Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)]
  • Fractional anisotropy (DTI) [Time frame: Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)]
  • Mean diffusivity (DTI) [Time frame: Day 0, Day 126-140, Day 365]
  • Cognitive performance score [Time frame: 0, Day 126-140, Day 365]
  • Patient-reported quality of life score [Time frame: Day 0, Day 126-140, Day 365]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Kepler University Hospital — Linz

Identifiers

NCT: NCT07612917 · 1419/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗