Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05043519|
Recruitment Status : Not yet recruiting
First Posted : September 14, 2021
Last Update Posted : September 14, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cranial Nerve Injuries||Drug: FAM-NP41||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||19 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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;
- 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.
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
|Contact: Chenlong YANG, MD, PhDemail@example.com|
|Contact: Jun YANG, MD, PhDfirstname.lastname@example.org|
|Responsible Party:||Peking University Third Hospital|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cranial Nerve Injuries
Cranial Nerve Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries