Phase I/II Clinical Trial of NP41 Molecular Targeted Fluorescence Imaging for Cranial Nerve Visualization During Neurosurgery
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
Preclinical evidence has shown that NP41 is a novel nerve-binding peptide with safe pharmacokinetics. Fluorescently labeled NP41 is effective for the intraoperative visualization of cranial nerves during neurosurgery. This Phase I/II clinical trial is aimed to investigate the safety and validity of FAM-NP41 for the fluorescence imaging of cranial nerves. In the Phase I trial, biological safety and adverse events will be evaluated, and pharmacokinetic parameters will be measured. In the Phase II trial, the sensitivity and specificity of FAM-NP41 for the fluorescence imaging of cranial nerves will be investigated, and the signal-to-background ratio will be calculated.
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
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enhanced brain MRI with or without cranial CT confirms a diagnosis of tumor in the anterior skull base, the middle cranial fossa, or the posterior cranial fossa. Structural images, DTI sequences and 3D-CISS sequences confirm that the tumor is adjacent to the cranial nerve or the cranial nerve will be exposed during the neurological surgery.
- •The body weight is within ±20% of standard body weight [0.7×(height cm-80)]kg;
- •The preoperative laboratory examination parameters of heart, lung, liver, kidney and blood are all in the normal range;
- •Be able to understand the potential risks and benefits of the clinical trial, and sign a written informed consent.
排除标准
- •Preoperative hepatorenal insufficiency: ALT or AST increased ≥ 2 times than the upper limit of normal range; serum creatinine > 2.0 mg/ dL (177 μmol/L) or glomerular filtration rate > 30 ml/min×1.73 m2;
- •Positive reaction in the allergy test, or allergic constitution (such as allergic to two or more foods/drugs, or known to be allergic to protein or to this polypeptide);
- •Preoperative imaging data (enhanced MRI) are incomplete;
- •Serious primary diseases involving important organs;
- •Mentally or physically disabled patients;
- •Alcohol abuse or long-term medication may affect the drug metabolism;
- •According to the judgment of the investigator, the potential intolerance to the drug (such as weak or severe malnutrition);
- •Primary or secondary cranial nerve dysfunction, such as facial paralysis, hearing loss caused by otitis media, etc.
- •Female patients undergoing neurosurgery during pregnancy or lactation.
研究组 & 干预措施
FAM-NP41 Fluorescence Imaging
The patients will be injected with FAM-NP41 preoperatively, and fluorescence imaging of cranial nerves will be evaluated after the craniotomy.
干预措施: FAM-NP41 (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: 0~24 hours after the drug administration
Half-life for distribution, half-life for elimination
Hepatorenal functions
时间窗: 0~72 hours after the drug administration
ALT, AST, BUN, Cr, GFR
Effectiveness for cranial nerve imaging
时间窗: Intraoperative period with cranial nerve exposure
Sensitivity, specificity, signal-to-background ratio
次要结局
- Adverse events(0~72 hours after the drug administration)
- Functions of cranial nerves(0~1 week after the drug administration)