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Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases

Clinical Study of [18F] PM-PBB3 PET Imaging of Tau Protein in Neurodegenerative Diseases

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06344845
Enrollment
80
Registered
2024-04-03
Start date
2022-11-01
Completion date
2025-11-30
Last updated
2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurodegenerative Diseases

Brief 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.

Interventions

DIAGNOSTIC_TEST18F-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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
49 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic PerformanceThrough study completion, an average of 1 yearDiagnostic performance including sensitivity, specificity, accuracy

Secondary

MeasureTime frameDescription
Clinical StageThrough study completion, an average of 1 yearClinical stage changed by 18F-PBB3 PET/CT compared to 18F-FDG PET/CT.

Countries

China

Contacts

Primary ContactChenhao Jia, M.D.
jiachenhao24@163.com86+18548703382

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026