Clinical Study to Assess the Positive Predictive Value of NPC-07 Induced Tissue Fluorescence in Patients With Malignant Glioma (WHO Grades III/IV)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Positive predictive value of tissue fluorescence
研究概览
简要总结
The aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent malignant glioma (WHO grades III/IV).
Positive predictive value will be confirmed by percentage of patients showing positive tumor cell identification in all biopsies taken from areas of strong and weak fluorescence. This study will be divided into two stages. After reviewing of the result of safety and pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring committee, more subjects will receive NPC-07 in Step II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years.
- •Radiological suspicion of newly- or recurrent malignant glioma (WHO grades III/IV).
- •Indication for surgical tumor resection.
- •Karnofsky Performance Score of 60 or higher.
- •Provides signed informed consent prior to any study procedures.
- •Comply with visit schedule and other rules for patients in study protocol.
排除标准
- •Porphyria, hypersensitivity to porphyrins.
- •Renal insufficiency: Creatinine 2.0 mg/dL or higher
- •Hepatic insufficiency: ALT 100 IU/L or higher, AST 100 IU/L or higher, γ-GTP 100 IU/L or higher or total bilirubin 3 mg/dL or higher
- •Chemotherapy or other treatment for other malignant tumors
- •Females who are pregnant or potentially childbearing or are breastfeeding
- •Participation in other clinical trial in the previous 1 month
- •Ineligible patient based on the judgement of the investigator.
研究组 & 干预措施
NPC-07
Single administration of NPC-07 at a dose of 20mg/kg body weight
干预措施: NPC-07 for oral administration (Drug)
结局指标
主要结局
Positive predictive value of tissue fluorescence
时间窗: 1 day
Positive predictive value of tissue fluorescence defined as the percentage of patients showing positive tumor cell identification in all 6 biopsies taken from areas of strong and weak fluorescence.
次要结局
- Percentage of patients without residual tumor(3 days)
- Quality of fluorescent tissue(1 day)
- Positive predictive value of tissue fluorescence in each biopsy tissue sample(1 day)
- Positive predictive value of non-fluorescent tissue at the biopsy level(1 day)
- Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).(1 day)
- Safety(28 days)
- Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2）(2 days)