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

Tracking Information

• First Submitted Date: September 7, 2021
• First Posted Date: September 14, 2021
• Last Update Posted Date: September 14, 2021
• Estimated Study Start Date: January 1, 2022
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 7, 2021)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 7, 2021)

• Adverse events [ Time Frame: 0~72 hours after the drug administration ]
  Allergic reaction, changes in vital signs
• Functions of cranial nerves [ Time Frame: 0~1 week after the drug administration ]
  Physical examination of cranial nerves

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging
• Official Title: Phase I/II Clinical Trial of NP41 Molecular Targeted Fluorescence Imaging for Cranial Nerve Visualization During Neurosurgery
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Cranial Nerve Injuries

Intervention

Drug: FAM-NP41

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

Study Arms

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.

Intervention: Drug: FAM-NP41

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 7, 2021): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: August 31, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Chenlong YANG, MD, PhD; +86-13511087060; vik.yang@pku.edu.cn

Contact: Jun YANG, MD, PhD; +86-13901291211; yangjbysy@bjmu.edu.cn

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05043519
• Other Study ID Numbers: S2021485
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Peking University Third Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Peking University Third Hospital
• Original Study Sponsor: Same as current
• Collaborators: Chinese Academy of Sciences
• Investigators: Not Provided
• PRS Account: Peking University Third Hospital
• Verification Date: August 2021