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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

18F-FDS PET/CT in Healthy Volunteers and Patients With Suspected Infection

NCT02450942

Enterobacteriaceae Infections

UNKNOWN EARLY_PHASE1

99mTc-CNDG SPECT/CT in Brain Tumors

NCT06362304

Intracranial Tumor

RECRUITING NA

Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

NCT03721055

Cancer Metastatic Cancer Metastatic Brain Cancer

UNKNOWN NA

FBY PET/CT in Patients With Brain Tumors

NCT03980431

Brain Tumor

UNKNOWN NA

Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy.

NCT00805636

Brain Metastases Solid Tumors

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

(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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patients With Central Nervous System Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

(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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes