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 range
19 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. According to the judgment of the investigator, the potential intolerance to the drug (such as weak or severe malnutrition);
. Primary or secondary cranial nerve dysfunction, such as facial paralysis, hearing loss caused by otitis media, etc.