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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

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

More Information

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT05043519
• Other Study ID Numbers: S2021485
• First Posted: September 14, 2021
• Last Update Posted: September 14, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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; Neurosurgery; Fluorescence Imaging; Molecular Probe; NP41

Additional relevant MeSH terms:

Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries