Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging

Phase 1

• Conditions: Cranial Nerve Injuries
• Interventions: Drug: FAM-NP41

• Registration Number: NCT05043519
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-14
• Study Start: 2022-01-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FAM-NP41 Fluorescence Imaging	FAM-NP41	The patients will be injected with FAM-NP41 preoperatively, and fluorescence imaging of cranial nerves will be evaluated after the craniotomy.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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