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

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ClinicalTrials.gov Identifier: NCT05043519
Recruitment Status : Not yet recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
Chinese Academy of Sciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cranial Nerve Injuries Drug: FAM-NP41 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I/II Clinical Trial of NP41 Molecular Targeted Fluorescence Imaging for Cranial Nerve Visualization During Neurosurgery
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FAM-NP41 Fluorescence Imaging
The patients will be injected with FAM-NP41 preoperatively, and fluorescence imaging of cranial nerves will be evaluated after the craniotomy.
Drug: FAM-NP41
The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.

Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 0~24 hours after the drug administration ]
    Half-life for distribution, half-life for elimination

  2. Hepatorenal functions [ Time Frame: 0~72 hours after the drug administration ]
    ALT, AST, BUN, Cr, GFR

  3. Effectiveness for cranial nerve imaging [ Time Frame: Intraoperative period with cranial nerve exposure ]
    Sensitivity, specificity, signal-to-background ratio

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 0~72 hours after the drug administration ]
    Allergic reaction, changes in vital signs

  2. Functions of cranial nerves [ Time Frame: 0~1 week after the drug administration ]
    Physical examination of cranial nerves

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043519

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Contact: Chenlong YANG, MD, PhD +86-13511087060 vik.yang@pku.edu.cn
Contact: Jun YANG, MD, PhD +86-13901291211 yangjbysy@bjmu.edu.cn

Sponsors and Collaborators
Peking University Third Hospital
Chinese Academy of Sciences
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT05043519    
Other Study ID Numbers: S2021485
First Posted: September 14, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
Cranial Nerve
Fluorescence Imaging
Molecular Probe
Additional relevant MeSH terms:
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Cranial Nerve Injuries
Cranial Nerve Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries