Healthy Clinical Trial - [18F]SF12051 for Imaging the 18-kDa Translocator

Status Completed

Clinical Trial Summary

Background: Inflammation in the brain plays a role in many diseases. Being able to measure inflammation in a person s brain might help to diagnose and treat these diseases. One protein (TSPO) appears in higher numbers when inflammation affects the brain. To see TSPO when a person s body is scanned, researchers need a substance called a radiotracer that will attach to this protein and no other molecules. Objective: This study will test whether a new radiotracer ([18F]SF12051) can make TSPO appear on PET scans of a person s brain and body. Eligibility: Healthy people aged 18 and older. Design: This study requires 2 to 4 visits to the clinic. All participants will be screened. They will have a physical exam. They will have blood tests and a test of their heart function. Some participants will have a positron emission tomography (PET) scan of the whole body. The radiotracer will be injected through a tube (catheter) placed in a vein in the arm. The PET scanner is a machine shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. The scan will take about 2 hours. Some participants will have a PET scan of just their head. After they are injected with the radiotracer, they will lie on a bed with their head in the scanner. Blood will be drawn from a catheter in the wrist during the scan. Some participants will have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a narrow bed that slides into a tube. ...

Clinical Trial Description

Study Description: This study is intended to provide information on the novel [18F]SF12051 radioligand and its ability to localize and measure TSPO in the brain and body of healthy individuals. Objectives: Primary Objective: To study the brain uptake of [18F]SF12051 and perform kinetic modeling of the [18F]SF12051 in the three different TSPO genotypes. Secondary Objectives: To study the brain retest characteristics, biodistribution and dosimetry of [18F]SF12051 in healthy subjects. Endpoints: Primary Endpoint: The distribution volume of the radioligand and stability over time calculated with compartmental modeling, attention paid to differences in mean distribution volumes between TSPO genotypes for determining genotype sensitivity. Secondary Endpoints: Retest variability and reliability and organtime- activity curves to determine biodistribution and dosimetry. ;

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT05564429
Study type	Interventional
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	Phase 1
Start date	February 2, 2023
Completion date	January 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

[18F]SF12051 for Imaging the 18-kDa Translocator Protein (TSPO) in Brain and Whole Body of Healthy Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms