NL-OMON52327尚未招募2 期
Clinical safety study on 5-Aminolevulinic acid (5-ALA) in children and adolescents with supratentorial brain tumors - 5-ALA in children and adolescents
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 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
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •- Age 3 - <18 years.
- •- First radiological diagnosis of intra-axial, supratentorial
- •contrast-enhancing tumor on MRI or recurrent supratentorial intra-axial brain
- •tumor (malignant glioma, astrocytoma, malignant ependymoma, astroblastoma,
- •AT/RT, Oligodendroglioma, etc.).
- •- Resection is part of therapeutic strategy with an emphasis on neurological
- •- 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
- •child-bearing age) and not breast-feeding (for at least 24 hours after Gliolan
- •intake). 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.
排除标准
- •- Posterior fossa tumors.
- •- Extra-axial tumors such as craniopharyngeoma.
- •- Germ cell tumor or entities precluding surgical resection.
- •- Acute or chronic porphyria.
- •- Hypersensitivity to 5-ALA or porphyrins.
- •- Renal insufficiency: serum creatinine > 2x upper limit of normal (ULN).
- •- Hepatic insufficiency: serum bilirubine > 2x ULN, serum γ-GT > 2,5 x ULN,
- •alanine transaminase (ALT) and aspartate transaminase (AST)> 2,5 ULN.
- •- 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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