Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging (NCT05043519) | Clinical Trial Compass
UnknownPhase 1/2
Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging
40 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range19 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
✓. The body weight is within ±20% of standard body weight \[0.7×(height cm-80)\]kg;
✓. The preoperative laboratory examination parameters of heart, lung, liver, kidney and blood are all in the normal range;
✓. Be able to understand the potential risks and benefits of the clinical trial, and sign a written informed consent.
Exclusion criteria
✕. 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;
✕. 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);
✕. Preoperative imaging data (enhanced MRI) are incomplete;
✕. Serious primary diseases involving important organs;
✕. Mentally or physically disabled patients;
✕. Alcohol abuse or long-term medication may affect the drug metabolism;
✕
What they're measuring
1
Pharmacokinetic parameters
Timeframe: 0~24 hours after the drug administration
2
Hepatorenal functions
Timeframe: 0~72 hours after the drug administration
3
Effectiveness for cranial nerve imaging
Timeframe: Intraoperative period with cranial nerve exposure