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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.
Pharmacokinetic parameters
Half-life for distribution, half-life for elimination
Time frame: 0~24 hours after the drug administration
Hepatorenal functions
ALT, AST, BUN, Cr, GFR
Time frame: 0~72 hours after the drug administration
Effectiveness for cranial nerve imaging
Sensitivity, specificity, signal-to-background ratio
Time frame: Intraoperative period with cranial nerve exposure
Adverse events
Allergic reaction, changes in vital signs
Time frame: 0~72 hours after the drug administration
Functions of cranial nerves
Physical examination of cranial nerves
Time frame: 0~1 week after the drug administration
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