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

Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Patients With Central Nervous System Diseases
• Intervention / Treatment: Diagnostic test: (S)-[18F]FBFP PET/CT

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Huo, MD; Phone Number: +86 13910801986; Email: huoli@pumch.cn
• Study Contact Backup: Name: Jingnan Wang, MD; Phone Number: +86 13126715080; Email: jingnanwang1991@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Yupei Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (S)-[18F]FBFP injection and PET/CT scan; Patients will be intravenously injected with(S)-[18F]FBFP and undergo PET/CT scan.	Diagnostic test: (S)-[18F]FBFP PET/CT; Patients will be intravenously injected with 185-370MBq (S)-[18F]FBFP and undergo serial whole-body PET/CT scans at multiple time points (5min, 15min, 30min, 45min, 1h, 2h, 4h). Safety assessment and tolerability of the study will be conducted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual and semiquantitative assessment of organs and biodistribution	Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of lesions or organs will be measured.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events collection	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed	1 week

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Normal University
• Investigators: Study Chair: Li Huo, MD, Peking Uion Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: PUMCHNM-SIGMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No