Cranial Nerve Injuries
Conditions
Keywords
Cranial Nerve, Neurosurgery, Fluorescence Imaging, Molecular Probe, NP41
Brief summary
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.
Interventions
DRUGFAM-NP41
The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.
Sponsors
Chinese Academy of Sciences
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. The body weight is within ±20% of standard body weight \[0.7×(height cm-80)\]kg; 3. The preoperative laboratory examination parameters of heart, lung, liver, kidney and blood are all in the normal range; 4. Be able to understand the potential risks and benefits of the clinical trial, and sign a written informed consent.
Exclusion criteria
1. 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; 2. 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); 3. Preoperative imaging data (enhanced MRI) are incomplete; 4. Serious primary diseases involving important organs; 5. Mentally or physically disabled patients; 6. Alcohol abuse or long-term medication may affect the drug metabolism; 7. According to the judgment of the investigator, the potential intolerance to the drug (such as weak or severe malnutrition); 8. Primary or secondary cranial nerve dysfunction, such as facial paralysis, hearing loss caused by otitis media, etc. 9. Female patients undergoing neurosurgery during pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters | 0~24 hours after the drug administration | Half-life for distribution, half-life for elimination |
| Hepatorenal functions | 0~72 hours after the drug administration | ALT, AST, BUN, Cr, GFR |
| Effectiveness for cranial nerve imaging | Intraoperative period with cranial nerve exposure | Sensitivity, specificity, signal-to-background ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 0~72 hours after the drug administration | Allergic reaction, changes in vital signs |
| Functions of cranial nerves | 0~1 week after the drug administration | Physical examination of cranial nerves |
Contacts
Primary ContactChenlong YANG, MD, PhD
Backup ContactJun YANG, MD, PhD
Outcome results
None listed