Brain Connectivity Changes in Glioma Patients During Treatment

NCT07612917 | Recruiting

• 1 other identifier: 1419/2025
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Glioma,; Magnetic Resonance Imaging, Functional; Brain Mapping; Neural Plasticity; Cognition

Outcome Measures

Primary Outcomes (2)

• Treatment-related changes in BOLD signal and diffusion tensor imaging (DTI) outcomes across different stages of 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.

  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)

Secondary Outcomes (5)

• BOLD functional MRI signal change

  Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)

• Fractional anisotropy (DTI)

  Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)

• Mean diffusivity (DTI)

  Day 0, Day 126-140, Day 365

• Cognitive performance score

  0, Day 126-140, Day 365

• Patient-reported quality of life score

  Day 0, Day 126-140, Day 365

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Raimund Kleiser, PD Dr.

  Neuroimaging Sciences and Support Center ,Clinical Institute for Neurosciences, Institute of Neuroradiology, Kepler Unisversity Hospital Linz, Johannes Kepler University

  STUDY CHAIR

• Andreas Gruber, Full Professor

  Head of Clinical Institute for Neurosciences, Head of the Departmend of Neurosurgery, Kepler Unisversity Hospital Linz, Johannes Kepler University

  STUDY CHAIR

• Hans Geinitz, Professor

  Head of Department of Radiation Oncology, Clinical Institute for Neurosciences

  STUDY CHAIR

• Michael Sonnberger, MD

  Head of Institute of Neuroradiology, Kepler University Hospital Linz, Johannes Kepler University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raimund Kleiser, PD Dr.

CONTACT

+43 5 7680 87 - 26701; raimund.kleiser@kepleruniklinikum.at

Mario Scheweder, MSc

CONTACT

+43 50 344 27125; mario.scheweder@kepleruniklinikum.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Linz

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 29, 2026

Record last verified: 2026-02

Locations

AU (1)