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

NCT05335200 | Unknown Phase 1

• 1 other identifier: PUMCHNM-SIGMA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Patients With Central Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse events collection

  1 week

Study Arms (1)

(S)-[18F]FBFP injection and PET/CT scan

EXPERIMENTAL

Patients will be intravenously injected with(S)-\[18F\]FBFP and undergo PET/CT scan.

Diagnostic Test: (S)-[18F]FBFP PET/CT

Interventions

(S)-[18F]FBFP PET/CT DIAGNOSTIC_TEST

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.

(S)-[18F]FBFP injection and PET/CT scan

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Normal University: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Study Officials

• Li Huo, MD

  Peking Uion Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Jingnan Wang, MD

CONTACT

+86 13126715080; jingnanwang1991@163.com

Li Huo, MD

CONTACT

+86 13910801986; huoli@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 19, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)