[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

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.

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Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 18F-SF12051

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 organtime- activity curves to determine biodistribution and dosimetry.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Robert B Innis, M.D.; Phone Number: (301) 594-1368; Email: robert.innis@nih.gov
• Study Contact Backup: Name: Tara N Turon, C.R.N.P.; Phone Number: (301) 496-9423; Email: tara.turon@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all of the following criteria:

• Aged 18 years or older.
• Healthy based on medical history, physical examination, and laboratory testing.
• Able to provide informed consent.
• Willing and able to complete all study procedures.
• Have been screened for TSPO genotype under 01-M-0254 "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants".
• Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists*.

• Agree to adhere to the lifestyle considerations

  • Does not apply to Phase 1 and 3 participants as they will not have an arterial line.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

• Clinically significant abnormalities on EKG or laboratory testing. This includes CBC; acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen); hepatic panel (alkaline phosphatase, ALT, AST, bilirubin total, and bilirubin direct); mineral panel (albumin, calcium, magnesium, phosphorus); prothrombin and partial prothrombin tests.
• Participants should not have taken NSAIDs or willow bark tea for two weeks prior to the PET scan.
• Any current Axis I diagnosis.
• Positive test for HIV.
• Unable to have an MRI scan*.
• History of neurologic illness or injury with the potential to affect study data interpretation.
• History of seizures, other than in childhood and related to fever.
• Recent exposure to radiation (i.e., PET from other research) which when combined with this study would be above the allowable limits.
• Inability to lie flat on camera bed for at least two hours, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
• Pregnancy or breast feeding.
• Able to get pregnant but does not use birth control.
• Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use affects the function of daily life.
• Unable to travel to NIH.

• NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.

  • Phase 1 and 3 participants will not get an MRI.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Only one arm; All subjects receive the same tests	Drug: 18F-SF12051; Injected IV followed by PET scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the brain uptake of [18F]SF12051 in healthy volunteers	to measure receptor density	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study retest variability and reliability of [18F]SF12051	for retest studies are variability and reliability calculating radiation burden	36 months

Collaborators and Investigators

• Sponsor: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Robert B Innis, M.D., National Institute of Mental Health (NIMH)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2023
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 25, 2024

More Information

Terms related to this study

• Keywords: Neuroinflammation; PET Imaging; Tspo
• Other Study ID Numbers: 10000674; 000674-M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .The results will be submitted to ClinicalTrials.gov
• IPD Sharing Time Frame: 18 months after closure of protocol
• IPD Sharing Access Criteria: BTRIS
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No