EUCTR2014-005669-54-DE进行中（未招募）1 期
Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with brain tumours - 5-ALA in children and adolescents
niversität Münster c/o Universitätsklinikum Münster, Geschäftsbereich Personal und Recht0 个研究点目标入组 80 人开始时间: 2019年12月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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 3 - <18 years
- •First radiological diagnosis of intra-axial, contrast-enhancing tumor on MRI or recurrent intra-axial brain tumor (malignant glioma, astrocytoma, malignant ependymoma, AT/RT, Oligodendroglioma, etc.)
- •Resection is part of therapeutic strategy with an emphasis on neurological safety
- •Informed consent by the parents or guardians and if possible assent of the patient after education of purpose and risks of study. Patients that are able to understand should provide assent to participate in the trial
- •Female adolescents: not pregnant (pregnancy test required for adolescents of childbearing age) and not breast-feeding.
- •Female patients of childbearing potential and male patients who are sexually active must be practising a highly effective method of birth control up to 6 weeks after the tumor operation consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Extra-axial tumors such as craniopharyngeoma
- •Tumors precluding surgical resection
- •Acute or chronic porphyria
- •Hypersensitivity to 5-ALA or porphyrins
- •Renal insufficiency: serum creatinine > 2x upper limit of normal
- •Hepatic insufficiency: serum bilirubine > 2x upper limit of normal, serum ?-GT > 2,5 x upper limit of normal, alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 upper limit of normal
- •Blood clotting: INR out of acceptable limits
- •Other malignant disease
- •Patients with pre-existing cardiovascular diseases
- •Co-administration with other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
- •Planned administration of potentially hepatotoxic substances within 24 hours after 5-ALA administration
研究者
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