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

NCT ID: NCT05043519

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Cranial Nerve Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FAM-NP41

Intervention Type: DRUG

The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.

Interventions

FAM-NP41

The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chenlong YANG, MD, PhD

Role: CONTACT

vik.yang@pku.edu.cn

+86-13511087060

Jun YANG, MD, PhD

Role: CONTACT

yangjbysy@bjmu.edu.cn

+86-13901291211

Other Identifiers

S2021485

Identifier Type: -

Identifier Source: org_study_id