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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06344845
Other study ID # PUMCH-NM-PBB3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date November 2025

Study information

Verified date March 2024
Source Peking Union Medical College Hospital
Contact Chenhao Jia, M.D.
Phone 86+18548703382
Email jiachenhao24@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In terms of the diagnostic technology of brain neurodegenerative diseases, the injection of positron tracers into the human body, so that it can combine with the corresponding protein, and show its distribution through PET imaging is a mature technology in the industry. At present, several research groups around the world are working on the development and clinical efficacy evaluation of their respective tau imaging agent compounds.This clinical research project intends to display the abnormal changes of tau protein in living brain through [18F]PM-PBB3 PET imaging, which is a second-generation tracer further optimized on the basis of [11C]PBB3, and has the advantages of closer binding to tau protein entanglement and less non-specific binding than similar imaging agents. Better image quality and a wider range of clinical applications.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 2025
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 49 Years to 80 Years
Eligibility Inclusion Criteria: - Between 45 and 90 years old; No gender limitation. Brain MRI supported the diagnosis of neurodegeneration, and there was no evidence of other neurological diseases. Informed consent signed in person by the subject or his legal guardian or caregiver. Exclusion Criteria: - Have other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases. Received an experimental drug or device within 1 month (whose efficacy or safety is unclear). patients who were unwilling to undergo PET/CT scans. pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
18F-PBB3 PET/CT scan
Patients with suspected neurodegeneration underwent PET/CT scan after injection of 370MBq (10 mCi)18F-FDG to observe for TAU deposition.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic Performance Diagnostic performance including sensitivity, specificity, accuracy Through study completion, an average of 1 year
Secondary Clinical Stage Clinical stage changed by 18F-PBB3 PET/CT compared to 18F-FDG PET/CT. Through study completion, an average of 1 year
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