NCT06678867尚未招募2 期
A Phase II Multicentre Trial for the Use of 5-ALA Paediatric Patients With High Grade Brain Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours.
研究概览
简要总结
The aim of the study is to examine the safety and feasibility of using 5-ALA in children who have MRI scans showing an aggressive looking brain tumour. It will also study if 5-ALA can help the surgeon achieve maximal tumour removal and discriminate between normal brain tissue and tumour.
Patients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Magnetic Resonance Imaging confirmation of diagnosis consistent with either: primary presentation of high grade brain tumour OR patient relapsing with previously confirmed ependymoma or high-grade glial tumour
- •Tumours will be either intrinsic supratentorial or infratentorial / posterior fossa, non-brainstem, tumours
- •Patient is appropriate for maximal safe resection of tumour, based on Investigator and Multidisciplinary Team judgement
- •3 - 18 years inclusive
- •Adequate liver and kidney function
- •creatinine - less than one and a half times the upper limit of normal.
- •haemoglobin above the lower limit of normal
- •Alanine transferase or Aspartate transferase less than twice the upper limit of normal (if both performed, then both results must be lower than twice the upper limit of normal
- •bilirubin lower than one and a half times the upper limit of normal
- •Normal Coagulation profile
- •o Prothombin Time, Activated Partial Prothombin Time and Thrombin Time all within normal limits
- •Urine porphyrin - Test to be completed and sent for analysis
- •Blood pressure lower than or equal to the upper limit of normal
- •Negative pregnancy test in women of childbearing potential*
- •Informed Consent *A positive pregnancy test that is suspected to be due to the location of the tumour is to be queried with the TMG prior to registration of the patient
排除标准
- •Patients with low grade tumours (either radiological or histological diagnosis)
- •Patient is appropriate for biopsy only, based on Investigator and MDT judgement
- •Known history (including family history) of porphyria
- •Hypersensitivity to the active substance or to porphyrins
- •History of light sensitivity reactions
- •Pregnant or breastfeeding women
研究组 & 干预措施
Patients with high grade brain tumours
Other
This is a single-arm study with two cohorts
干预措施: 5-ALA (Gliolan) (Drug)
结局指标
主要结局
Cohort 1: Complete resection rate and fluorescence rate of supratentorial instrinsic high grade brain tumours. Cohort 2: Fluorescence rate of infratentorial tumours.
时间窗: Two weeks
Timeframe between informed consent and surgery
次要结局
未报告次要终点
研究者
研究点 (1)
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