Clinical Applications of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases

  • End date
    Dec 30, 2024
  • participants needed
  • sponsor
    Peking Union Medical College Hospital
Updated on 30 April 2022
Accepts healthy volunteers


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 diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases. A single dose of nearly 370 MBq (S)-[18F]FBFP will be intravenously injected into healthy volunteers and patients with central nervous system diseases. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.


(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 membrane. Several lines of evidence have demonstrated that the sigma-1 receptor plays a pivotal role in the pathophysiology of many neuropsychiatric disorders including amyotrophic lateral sclerosis, Alzheimer's disease, Parkinson's disease, Huntington's disease, pain, depression and drug addiction.Therefore, it is an important target for the investigation of neuropsychiatric disorders and drug development. PET imaging of sigma-1 receptors in the human brain will enable the elucidation of this target's involvement in neurologic disorders and will also facilitate new drug development.

For further interests in clinical translation of PET sigma-1 receptors radioligands, (S)-[18F]FBFP, an open-label whole-body PET/CT study was designed to investigate radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases.

Condition Patients With Central Nervous System Diseases
Treatment (S)-[18F]FBFP PET/CT
Clinical Study IdentifierNCT05335200
SponsorPeking Union Medical College Hospital
Last Modified on30 April 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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