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NCT Number: NCT07612917

Brain Connectivity Changes in Glioma Patients During Treatment

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.

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Key information

Conditions

Glioma (Any Grade) in the Brain Glioma Gliomas, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neurocognitive Function Neuroectodermal Tumors fMRI Research

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

    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.

  2. 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)

    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.

Secondary outcomes

  1. BOLD functional MRI signal change

    Time frame: 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.

  2. Fractional anisotropy (DTI)

    Time frame: 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.

  3. Mean diffusivity (DTI)

    Time frame: Day 0, Day 126-140, Day 365

    Mean diffusivity values derived from diffusion tensor imaging (DTI).

  4. Cognitive performance score

    Time frame: 0, Day 126-140, Day 365

    Cognitive performance assessed using standardized neuropsychological test scores.

  5. Patient-reported quality of life score

    Time frame: Day 0, Day 126-140, Day 365

    Patient-reported quality of life measured using validated questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Mario Scheweder, MSc

CONTACT

[email protected]

+43 50 344 27125

Raimund Kleiser, PD Dr.

CONTACT

[email protected]

+43 5 7680 87 - 26701

Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Collaborators

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

Registry information

Official study title

Functional Reorganization and Connectivity in Glioma Patients During the Therapeutic Trajectory

Acronym: GliRecon

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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