Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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. |
Drug: FAM-NP41
The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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The body weight is within ±20% of standard body weight [0.7×(height cm-80)]kg;
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The preoperative laboratory examination parameters of heart, lung, liver, kidney and blood are all in the normal range;
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Be able to understand the potential risks and benefits of the clinical trial, and sign a written informed consent.
Exclusion Criteria:
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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;
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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);
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Preoperative imaging data (enhanced MRI) are incomplete;
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Serious primary diseases involving important organs;
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Mentally or physically disabled patients;
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Alcohol abuse or long-term medication may affect the drug metabolism;
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According to the judgment of the investigator, the potential intolerance to the drug (such as weak or severe malnutrition);
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Primary or secondary cranial nerve dysfunction, such as facial paralysis, hearing loss caused by otitis media, etc.
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Female patients undergoing neurosurgery during pregnancy or lactation.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking University Third Hospital
- Chinese Academy of Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S2021485