EUCTR2017-002183-41-NL进行中（未招募）1 期
PET for Registration of Inflammation in the Vascular wall of IntracranialAneurysms
MCG0 个研究点目标入组 10 人开始时间: 2017年7月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 year
- •Presence of an unruptured intracranial aneurysm
- •Standard of care decision to treat the aneurysm
- •The aneurysm is surgically accessible
- •Aneurysm wall sampling is deemed possible by the surgeon
- •Written informed consent is obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Technical impairments to perform the study
- •? Incapacity to lie in prone position for 60 minutes
- •? Aneurysm size smaller than PET detection rate (<7 mm)
- •? Physical restrictions, e.g. morbid obesity
- •? Claustrophobia
- •o Evidence of active infection requiring antibiotic therapy
- •o Pregnancy or lactation
- •o Renal insufficiency (estimated glomerular filtration rate < 60
- •ml/min/1.73 m2)
- •o Known allergy to gadolinium contrast agent
- •o Patients with pacemakers, defibrillators, other implanted electronic
- •devices, or possible metal particles
- •o Treatment with metformin
- •o Multiple myeloma (Kahlers disease)
- •o Waldenstrom macroglobulinemia
- •o Myasthenia gravis
- •o Pheochromocytoma
- •o Mastocytosis
- •o Thyroid cancer
- •o Planned thyroid scan
研究者
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