NL-OMON53258招募中不适用
Precision Radiation treatment for Epilepsy - PRECISIO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 188
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years
- •2 Before patient registration/randomization, written informed consent must be
- •given according to ICH/GCP, and national/local regulations
- •3. Willingness to use contraception by a method that is deemed effective by the
- •Investigator during the SRT treatment and for at least 30 days following the
- •SRT therapy
- •4.The patient or caretaker is able to keep an epilepsy diary
- •5. The patient has a diagnosis of epilepsy established by a dedicated
- •neurologist
- •6. The patient had at least 3 focal-onset seizures over a 3-month period
- •despite two or more antiepileptic medication trials (according ILAE Task Force
- •on therapeutic strategies)
- •7. Video electroencephalography and work-up in the epilepsy surgery working
- •group to determine a well-circumscribed seizure focus is available
- •8. Evidence (e.g. 3T-MRI or a clear SEEG delineation) of the anatomic region to
- •be targeted with SRT, correlating with the EZ hypothesis;
- •9. A functional MRI to lateralize language or localize visual, motor and/or
- •sensory eloquent cortex *has been performed in selected patients (if the lesion
- •is expected to be located, based on anatomy, in the language areas).
- •10.The patient has completed a standard battery of neuropsychological testing
- •11.The patient been deemed an appropriate candidate for stereotactic
- •radiosurgery by a dedicated Radiation Oncologist and
- •Neurosurgeon/Epileptologist and referred for the study by one of the Dutch
- •regional multidisciplinary epilepsy surgery working groups
- •12. Patients that were rejected for surgery in an earlier stage can participate
- •in the trial if the last change of the NVS/DBS settings were more than 1 year
- •ago or NVS/DBS was not (yet) tried.
- •Informal caregivers:
- •1. Age >= 18 years
- •2. Understanding of Dutch language
排除标准
- •1. Pregnancy
- •2. If a radiation treatment plan without exceeding the constraints for the
- •organs at risk is not feasible.
- •3. Prior cranial radiotherapy
- •4. If radiotherapy treatment is not possible for diverse reasons.
- •5. If the subject has clinically significant and uncontrolled major other
- •medical condition(s) including but not limited to:
- •- psychiatric illness/social situation that would limit compliance with study
- •requirements
- •- any medical condition, with the opinion of the study investigator, places the
- •subject at an unacceptably high risk for toxicities
- •- Progressive co-morbidity which limits overall survival.
- •Informal caregivers:
- •1. No signed informed consent
研究者
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