Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 入组人数
- 21
- 主要终点
- Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).
研究概览
简要总结
This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
- •Indication for surgical tumour resection
- •First operation of the tumour, no other tumour-specific pre-treatment
- •Karnofsky Performance Scale 70%
- •Patient's written informed consent
- •Age 18-75 years
排除标准
- •Porphyria, hypersensitivity to porphyrins
- •Renal insufficiency:
- •Creatinine > 2.0 mg/dl
- •Hepatic insufficiency:
- •Bilirubin > 3 mg/dl
- •Quick test < 60 %
- •GT > 100 U/I
- •Other known malignancy (except basaliomas)
- •Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)
- •Inadequate contraception (condom)
- •Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
- •Simultaneous participation or participation in another clinical trial in the preceding 30 days
结局指标
主要结局
Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).
时间窗: Within 3 hours
After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically.
次要结局
未报告次要终点