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| Name | Class |
|---|---|
| Chinese Academy of Sciences | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAM-NP41 Fluorescence Imaging | Experimental | The patients will be injected with FAM-NP41 preoperatively, and fluorescence imaging of cranial nerves will be evaluated after the craniotomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAM-NP41 | Drug | The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Half-life for distribution, half-life for elimination | 0~24 hours after the drug administration |
| Hepatorenal functions | ALT, AST, BUN, Cr, GFR | 0~72 hours after the drug administration |
| Effectiveness for cranial nerve imaging | Sensitivity, specificity, signal-to-background ratio | Intraoperative period with cranial nerve exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Allergic reaction, changes in vital signs | 0~72 hours after the drug administration |
| Functions of cranial nerves | Physical examination of cranial nerves |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenlong YANG, MD, PhD | Contact | +86-13511087060 | vik.yang@pku.edu.cn | |
| Jun YANG, MD, PhD | Contact | +86-13901291211 | yangjbysy@bjmu.edu.cn |
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| ID | Term |
|---|---|
| D020209 | Cranial Nerve Injuries |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| 0~1 week after the drug administration |
| D014947 | Wounds and Injuries |