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

NCT05335200 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-04-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Normal University

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Li Huo, MD · Peking Uion Medical College Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05335200 on ClinicalTrials.gov