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| Name | Class |
|---|---|
| Clinical Research Institute for Neurosciences, JKU Linz, Austria | UNKNOWN |
| Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Lin | UNKNOWN |
| Department of Neurosurgery, Kepler University Hospital, Johannes Kepler University Linz |
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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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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| BOLD functional MRI signal change | Brain activation measured as blood oxygen level-dependent (BOLD) signal change using functional MRI during task-based acquisition. | Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up) |
| Fractional anisotropy (DTI) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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Adults with diffuse gliomas (WHO grade 2-4) undergoing multimodal treatment and eligible for functional MRI and neurocognitive assessment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kepler University Hospital | Recruiting | Linz | Upper Austria | 4020 | Austria |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| UNKNOWN |
| Department of Radiation Oncology, Ordensklinikum Linz, Barmherzige Schwestern, Linz, Austria | UNKNOWN |
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Fractional anisotropy values derived from diffusion tensor imaging (DTI) assessed during treatment and follow-up. |
| 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). | Day 0, Day 126-140, Day 365 |
| Cognitive performance score | Cognitive performance assessed using standardized neuropsychological test scores. | 0, Day 126-140, Day 365 |
| Patient-reported quality of life score | Patient-reported quality of life measured using validated questionnaires. | Day 0, Day 126-140, Day 365 |
| 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 |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |