Glioma (Any Grade) in the BrainGliReconNCT07612917
Brain Connectivity Changes in Glioma Patients During Treatment
An observational study of Glioma (Any Grade) in the Brain and Gliomas, Malignant, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Glioma (Any Grade) in the Brain, Gliomas, Malignant, fMRI Research
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with diffuse gliomas (WHO grade 2-4) undergoing multimodal treatment and eligible for functional MRI and neurocognitive assessment.
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Kepler University Hospital
Linz, Upper Austria, 4020
About this study
Official title: 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:
Read more
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
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 0 (pre-neurosurgery baseline) and Day 365 (one-year follow-up)
Secondary outcomes (5)
BOLD functional MRI signal change
Brain activation measured as blood oxygen level-dependent (BOLD) signal change using functional MRI during task-based acquisition.
Measured: Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Fractional anisotropy (DTI)
Fractional anisotropy values derived from diffusion tensor imaging (DTI) assessed during treatment and follow-up.
Measured: Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
Mean diffusivity (DTI)
Mean diffusivity values derived from diffusion tensor imaging (DTI).
Measured: Day 0, Day 126-140, Day 365
Cognitive performance score
Cognitive performance assessed using standardized neuropsychological test scores.
Measured: 0, Day 126-140, Day 365
Patient-reported quality of life score
Patient-reported quality of life measured using validated questionnaires.
Measured: Day 0, Day 126-140, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 May 2026
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma (Any Grade) in the BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Michael Sonnberger, Johannes Kepler University of Linz
- Investigators
- Raimund Kleiser, PD Dr., Study chair, Neuroimaging Sciences and Support Center ,Clinical Institute for Neurosciences, Institute of Neuroradiology, Kepler Unisversity Hospital Linz, Johannes Kepler UniversityAndreas Gruber, Full Professor, Study chair, Head of Clinical Institute for Neurosciences, Head of the Departmend of Neurosurgery, Kepler Unisversity Hospital Linz, Johannes Kepler UniversityHans Geinitz, Professor, Study chair, Head of Department of Radiation Oncology, Clinical Institute for NeurosciencesMichael Sonnberger, MD, Principal investigator, Head of Institute of Neuroradiology, Kepler University Hospital Linz, Johannes Kepler University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612917
- Sponsor's protocol ID
- 1419/2025
- Acronym
- GliRecon
- Status last verified
- Aug 2026
- First submitted
- 8 May 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Reorganization and Connectivity in Glioma Patients During the Therapeutic Trajectory
- ClinicalTrials.gov ID
- NCT07612917
- Acronym / sponsor ID
- GliRecon / 1419/2025
- Conditions
- Glioma (Any Grade) in the Brain, Gliomas, Malignant, fMRI Research, Neurocognitive Function
- Keywords
- Glioma,, Magnetic Resonance Imaging, Functional, Brain Mapping, Neural Plasticity, Cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- 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
- Study start
- 1 May 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with diffuse gliomas (WHO grade 2-4) undergoing multimodal treatment and eligible for functional MRI and neurocognitive assessment.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- Age <18 years or >65 years.
- Pregnancy.
- Contraindications to MRI, including but not limited to:
- Cerebral metastases from secondary (non-primary) tumors.
- Absence of baseline BOLD functional MRI and/or baseline neurocognitive assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma (Any Grade) in the Brain and Gliomas, Malignant, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raimund Kleiser, PD Dr. (+43 5 7680 87 - 26701, raimund.kleiser@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.