Functional Reorganization and Connectivity in Glioma Patients During the Therapeutic Trajectory
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Treatment-related changes in BOLD signal and diffusion tensor imaging (DTI) outcomes across different stages of treatment.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
Investigators
Michael Sonnberger
Head of Institute of Neuroradiology, Kepler University Hospital, Johannes Kepler University, Linz
Johannes Kepler University of Linz