Cranial Nerve InjuriesPhase 1/2NCT05043519
Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging
A Phase 1/2 study testing FAM-NP41 in people with Cranial Nerve Injuries, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- Cranial Nerve Injuries
- What is being tested?
- FAM-NP41
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
- Female patients undergoing neurosurgery during pregnancy or lactation.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase I/II Clinical Trial of NP41 Molecular Targeted Fluorescence Imaging for Cranial Nerve Visualization During Neurosurgery
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.
- Conditions
- Cranial Nerve Injuries
- Being tested
- FAM-NP41
- Keywords
- Cranial Nerve, Neurosurgery, Fluorescence Imaging, Molecular Probe, NP41
- Medical subject headings
- Cranial Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAM-NP41Drug
The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.
| Study group | Role | What they receive |
|---|---|---|
| FAM-NP41 Fluorescence Imaging | Experimental | The patients will be injected with FAM-NP41 preoperatively, and fluorescence imaging of cranial nerves will be evaluated after the craniotomy. Receives: Drug: FAM-NP41 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Half-life for distribution, half-life for elimination
Measured: 0~24 hours after the drug administration
Hepatorenal functions
ALT, AST, BUN, Cr, GFR
Measured: 0~72 hours after the drug administration
Effectiveness for cranial nerve imaging
Sensitivity, specificity, signal-to-background ratio
Measured: Intraoperative period with cranial nerve exposure
Secondary outcomes (2)
Adverse events
Allergic reaction, changes in vital signs
Measured: 0~72 hours after the drug administration
Functions of cranial nerves
Physical examination of cranial nerves
Measured: 0~1 week after the drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043519
- Sponsor's protocol ID
- S2021485
- Status last verified
- Aug 2021
- First submitted
- 7 Sep 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial of NP41 Molecular Targeted Fluorescence Imaging for Cranial Nerve Visualization During Neurosurgery
- ClinicalTrials.gov ID
- NCT05043519
- Acronym / sponsor ID
- S2021485
- Conditions
- Cranial Nerve Injuries
- Keywords
- Cranial Nerve, Neurosurgery, Fluorescence Imaging, Molecular Probe, NP41
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAM-NP41 Fluorescence Imaging | Experimental | Drug: FAM-NP41The patients will be injected with FAM-NP41 preoperatively, and fluorescence imaging of cranial nerves will be evaluated after the craniotomy. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAM-NP41The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision. | Drug | FAM-NP41 Fluorescence Imaging |
Primary outcome
Pharmacokinetic parameters
Time frame: 0~24 hours after the drug administration
Half-life for distribution, half-life for elimination
Hepatorenal functions
Time frame: 0~72 hours after the drug administration
ALT, AST, BUN, Cr, GFR
Effectiveness for cranial nerve imaging
Time frame: Intraoperative period with cranial nerve exposure
Sensitivity, specificity, signal-to-background ratio
2 secondary outcomes
Adverse events
Time frame: 0~72 hours after the drug administration
Functions of cranial nerves
Time frame: 0~1 week after the drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FAM-NP41 in people with Cranial Nerve Injuries, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chenlong YANG, MD, PhD (+86-13511087060, vik.yang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters (time frame: 0~24 hours after the drug administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.