Brain Connectivity Changes in Glioma Patients During Treatment (GliRecon)
2026年8月11日 更新者：Michael Sonnberger、Johannes Kepler University of Linz
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:
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.
研究概览
地位
招聘中
研究类型
观察性的
注册 (估计的)
20
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Raimund Kleiser, PD Dr.
- 电话号码：+43 5 7680 87 - 26701
- 邮箱：raimund.kleiser@kepleruniklinikum.at
研究联系人备份
- 姓名：Mario Scheweder, MSc
- 电话号码：+43 50 344 27125
- 邮箱：mario.scheweder@kepleruniklinikum.at
学习地点
-
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Upper Austria
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Linz、Upper Austria、奥地利、4020
- 招聘中
- Kepler University Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
Adults with diffuse gliomas (WHO grade 2-4) undergoing multimodal treatment and eligible for functional MRI and neurocognitive assessment.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment-related changes in BOLD signal and diffusion tensor imaging (DTI) outcomes across different stages of treatment.
大体时间：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.
|
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.
大体时间：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.
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Day 0 (pre-neurosurgery baseline) and Day 365 (one-year follow-up)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
BOLD functional MRI signal change
大体时间：Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
|
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)
|
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Fractional anisotropy (DTI)
大体时间：Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
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Fractional anisotropy values derived from diffusion tensor imaging (DTI) assessed during treatment and follow-up.
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Day 0 (pre-neurosurgery baseline), Day 126-140 (post-treatment), Day 365 (one-year follow-up)
|
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Mean diffusivity (DTI)
大体时间：Day 0, Day 126-140, Day 365
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Mean diffusivity values derived from diffusion tensor imaging (DTI).
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Day 0, Day 126-140, Day 365
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Cognitive performance score
大体时间：0, Day 126-140, Day 365
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Cognitive performance assessed using standardized neuropsychological test scores.
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0, Day 126-140, Day 365
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Patient-reported quality of life score
大体时间：Day 0, Day 126-140, Day 365
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Patient-reported quality of life measured using validated questionnaires.
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Day 0, Day 126-140, Day 365
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Raimund Kleiser, PD Dr.、Neuroimaging Sciences and Support Center ,Clinical Institute for Neurosciences, Institute of Neuroradiology, Kepler Unisversity Hospital Linz, Johannes Kepler University
- 学习椅：Andreas Gruber, Full Professor、Head of Clinical Institute for Neurosciences, Head of the Departmend of Neurosurgery, Kepler Unisversity Hospital Linz, Johannes Kepler University
- 学习椅：Hans Geinitz, Professor、Head of Department of Radiation Oncology, Clinical Institute for Neurosciences
- 首席研究员：Michael Sonnberger, MD、Head of Institute of Neuroradiology, Kepler University Hospital Linz, Johannes Kepler University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月1日
初级完成 (估计的)
2029年9月1日
研究完成 (估计的)
2029年12月1日
研究注册日期
首次提交
2026年5月8日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年5月29日
研究记录更新
最后更新发布 (实际的)
2026年8月13日
上次提交的符合 QC 标准的更新
2026年8月11日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.