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RecruitingNCT07612917GliReconUpdated Aug 13, 2026

Brain Connectivity Changes in Glioma Patients During Treatment

An observational study in Glioma (Any Grade) in the Brain, Gliomas, Malignant and fMRI Research, sponsored by Johannes Kepler University of Linz. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Johannes Kepler University of Linz · Observational

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Glioma,
  • Magnetic Resonance Imaging, Functional
  • Brain Mapping
  • Neural Plasticity
  • Cognition
03

In context

Glioma

1,452 studies on the registry are indexed under Glioma; 349 are open to participants now.

This study's planned enrollment of 20 is below the median of 90 across 273 observational studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Johannes Kepler University of Linz is the lead sponsor of 33 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years or >65 years.
  • Pregnancy.
  • 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 from secondary (non-primary) tumors.
  • Absence of baseline BOLD functional MRI and/or baseline neurocognitive assessment.
  • Failure to provide written participant information and .
  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0 (pre-neurosurgery baseline), Day 28 (post-surgery/pre-radiotherapy), and Day 126 to Day 140 (post-treatment)

  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.

    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.

    Time frame: Day 0 (pre-neurosurgery baseline) and Day 365 (one-year follow-up)

Secondary outcomes

  1. BOLD functional MRI signal change

    Brain activation measured as blood oxygen level-dependent (BOLD) signal change using functional MRI during task-based acquisition.

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

  2. Fractional anisotropy (DTI)

    Fractional anisotropy values derived from diffusion tensor imaging (DTI) assessed during treatment and follow-up.

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

  3. Mean diffusivity (DTI)

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

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

  4. Cognitive performance score

    Cognitive performance assessed using standardized neuropsychological test scores.

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

  5. Patient-reported quality of life score

    Patient-reported quality of life measured using validated questionnaires.

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

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07612917
Lead sponsor
Johannes Kepler University of Linz
Collaborators
Clinical Research Institute for Neurosciences, JKU Linz, Austria, Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Linz, Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University Linz, Department of Radiation Oncology, Ordensklinikum Linz, Barmherzige Schwestern, Linz
Responsible party
Michael Sonnberger (Head of Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Linz, Johannes Kepler University of Linz) — Principal investigator
First posted
May 29, 2026
Start date
May 1, 2026
Primary completion
Sep 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Aug 13, 2026

Study contacts

Raimund Kleiser, PD Dr.
Contact
raimund.kleiser@kepleruniklinikum.at
+43 5 7680 87 - 26701
Mario Scheweder, MSc
Contact
mario.scheweder@kepleruniklinikum.at
+43 50 344 27125
Raimund Kleiser, PD Dr.
study chair · Neuroimaging Sciences and Support Center ,Clinical Institute for Neurosciences, Institute of Neuroradiology, Kepler Unisversity Hospital Linz, Johannes Kepler University
Andreas Gruber, Full Professor
study chair · Head of Clinical Institute for Neurosciences, Head of the Departmend of Neurosurgery, Kepler Unisversity Hospital Linz, Johannes Kepler University
Hans Geinitz, Professor
study chair · Head of Department of Radiation Oncology, Clinical Institute for Neurosciences
Michael Sonnberger, MD
principal investigator · Head of Institute of Neuroradiology, Kepler University Hospital Linz, Johannes Kepler University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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