Clinical trial NCT05043519: Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging
Official title: Phase I/II Clinical Trial of NP41 Molecular Targeted Fluorescence Imaging for Cranial Nerve Visualization During Neurosurgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cranial Nerve Injuries
Keywords: Cranial Nerve
Neurosurgery
Fluorescence Imaging
Molecular Probe
NP41
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2021-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: 0~24 hours after the drug administration
measure: Hepatorenal functions
timeFrame: 0~72 hours after the drug administration
measure: Effectiveness for cranial nerve imaging
timeFrame: Intraoperative period with cranial nerve exposure
Secondary outcomes:
measure: Adverse events
timeFrame: 0~72 hours after the drug administration
measure: Functions of cranial nerves
timeFrame: 0~1 week after the drug administration
Other outcomes:
Locations:
Study officials:
References: