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

NCT06344845 | Recruiting

• 1 other identifier: PUMCH-NM-PBB3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance

  Diagnostic performance including sensitivity, specificity, accuracy

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Clinical Stage

  Through study completion, an average of 1 year

Study Arms (1)

Experimental: 18F-PBB3 PET/CT

EXPERIMENTAL

Inject18F-PBB3 and then perform PET/CT scan.

Diagnostic Test: 18F-PBB3 PET/CT scan

Interventions

18F-PBB3 PET/CT scan DIAGNOSTIC_TEST

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

Experimental: 18F-PBB3 PET/CT

Eligibility Criteria

• Age: 49 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Ruixue Cui, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenhao Jia, M.D.

CONTACT

86+18548703382; jiachenhao24@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

CN (1)