Status:
UNKNOWN
Clinical Applications of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Beijing Normal University
Conditions:
Patients With Central Nervous System Diseases
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
This is an open-label whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnost...
Detailed Description
(S)-\[18F\]FBFP is a promising sigma-1 receptor radioligand. The sigma-1 receptor is a unique chaperone protein with 223 amino acids located at the mitochondria-associated endoplasmic reticulum membra...
Eligibility Criteria
Inclusion
- Healthy volunteers: Males and females, ≥18 years old
- Patients With Central Nervous System Diseases: Patients with suspicion or diagnosis of central nervous system diseases after systemic neuropsychiatric assessment by experienced neurologists, having other imaging examination like CT or MRI, being able to provide basic information and sign the written informed consent form.
Exclusion
- Females planning to bear a child recently or with childbearing potential
- Known severe allergy or hypersensitivity to \[18F\] radionuclides.
- Kidney or liver failure.
- Patients not able to enter the bore of the PET/CT scanner.
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05335200
Start Date
April 1 2022
End Date
December 1 2024
Last Update
April 19 2022
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China