JPRN-jRCTs031180360已完成1 期
Photodynamic Therapy (PDT) for malignant brain tumor in children.
kawamata takakazu0 个研究点目标入组 5 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
We conducted a phase I/II clinical study of PDT for malignant brain tumors in children. No adverse events corresponding to CTCAE grade 3 or higher were observed, indicating that TS can be used safely in children. However, the efficacy of PDT, another objective of this study, could not be demonstrated due to the small number of cases and the diverse clinical backgrounds, including histological diagnosis and treatment received.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6age 至 20age（—）
- 性别
- All
入选标准
- •1. Patients treated at the department of neurosurgery, Tokyo Women's Medical University, Tokyo, Japan(in both outpatient clinic and admission).
- •2. Man and woman, over the age of 6 years old and below the age of 20 years old at enrollment.
- •3. In an initial case, patients who are highly suspicious for primary malignant brain tumor from pre-operative neuro-imaging. In a recurrent case, patient who is diagnosed as primary malignant brain tumor at previous histopathological diagnosis.
排除标准
- •1. Patients without surgical tumor removal.
- •2. Unusable for Talaporfin Sodium.
- •3. Non intended histopathological types of brain tumor.
- •4. Patients necessary for VEP monitoring.
- •5. Pregnancy or possibility of pregnancy.
- •6. Patients who are expected poor compliance with light shielding protection.
- •7. Patients regarded as ineligible by principal investigator.
研究者
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