Brain Connectivity Changes in Glioma Patients During Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorJohannes Kepler University of Linz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Age <18 years or >65 years.
Pregnancy.
Active medical implants (e.g., pain pump, defibrillator, cardiac pacemaker),
Orthodontic braces,
Trial population
Adults with diffuse gliomas (WHO grade 2-4) undergoing multimodal treatment and eligible for functional MRI and neurocognitive assessment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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 3654
Cognitive performance score
Cognitive performance assessed using standardized neuropsychological test scores.
Time frame
0, Day 126-140, Day 365Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johannes Kepler University of Linz
Lead sponsor
Clinical Research Institute for Neurosciences, JKU Linz, Austria
Collaborator
Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Linz
Collaborator
Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University Linz
Collaborator
Department of Radiation Oncology, Ordensklinikum Linz, Barmherzige Schwestern, Linz
Collaborator
Source ClinicalTrials.gov