NCT06417281已完成3 期
A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2024年6月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
研究概览
简要总结
This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient's written informed consent
- •Age 18-75 years
- •Radiological suspicion of a malignant glioma
- •Indication for surgical tumour resection
- •Karnofsky Performance Status (KPS) ≥ 70
排除标准
- •Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem
- •Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases；
- •known hypersensitivity to the test drug ingredients
- •Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;
研究组 & 干预措施
5 Aminolevulinic Acid
Experimental
This is an single arm study.
干预措施: 5 Aminolevulinic Acid (Drug)
结局指标
主要结局
positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites
时间窗: within 48 hours after surgery
The proportion of biopsy tissues diagnosed as malignant glioma cells positive by pathological examination among all tissues collected from both fluorescent and weakly fluorescent areas.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
PAlbociclib and Circulating Tumor DNA for ESR1 Mutation DetectionMetastatic Breast CancerNCT03079011UNICANCER1,017
招募中
3 期
A Study of SKLB1028 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory (R/R) AML With FLT3-MutatedAcute Myeloid Leukemia (AML)NCT04716114CSPC ZhongQi Pharmaceutical Technology Co., Ltd.315
已完成
3 期
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma PatientsOral Mucositis (Ulcerative) Due to RadiationNCT03387774Sun Yat-sen University179
已完成
3 期
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian CancerOvarian CancerNCT03180307On Target Laboratories, LLC140
进行中（未招募）
3 期
A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)Small Cell Lung CancerNCT06500026Sichuan Baili Pharmaceutical Co., Ltd.722