NCT05564429

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: National Institute of Mental Health (NIMH) · NIH
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed 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 organ time- activity curves to determine biodistribution and dosimetry.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	18F-SF12051	Injected intravenously followed by PET scanning

Timeline

• Start date: 2023-02-02
• Primary completion: 2023-05-09
• Completion: 2024-01-30
• First posted: 2022-10-03
• Last updated: 2024-07-09
• Results posted: 2024-07-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study