Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- medac GmbH
- 入组人数
- 415
- 主要终点
- 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
研究概览
简要总结
The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.
详细描述
Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally considered beneficial but complete resection of contrast enhancing tumor is achieved in less than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing tumor intraoperatively.
Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in malignant gliomas, a phenomenon under exploration for intraoperative identification and resection of these tumors. This study investigated the benefit derived from fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival and morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma).
- •Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection.
- •First operation of the tumour, no other tumour-specific pretreatment
- •Karnofsky at least 70 %
- •Patient's written informed consent
- •Age 18-72 years
排除标准
- •Tumour location in the midline, basal ganglia, cerebellum or brain stem
- •More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases
- •Porphyria, hypersensitivity to porphyrins
- •Renal insufficiency: Creatinine > 2.0 mg/dl
- •Hepatic insufficiency: Bilirubin > 3 mg/dl
- •Quick test < 60 %
- •gamma-GT > 70 U/I
- •Malignancies other than basaliomas
- •Existing or planned pregnancy or lactation, or inadequate contraception
- •Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation
研究组 & 干预措施
5-aminolevulinic acid
干预措施: 5-aminolevulinic acid (5-ALA) (Drug)
结局指标
主要结局
1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
时间窗: Within 72 hours after surgery
2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO).
时间窗: Within 6 month after surgery
次要结局
- 1. Overall survival.(Until 18 months after surgery)
- 2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment(Until 18 months after surgery)
- 3. Volume of residual tumour(After surgery)
- 4. Toxicity after oral administration of 5-Aminolevulinic acid.(Until 18 month after surgery)
- 5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment(Until 18 month after surgery)