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HealthyPhase 1NCT05564429

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

A Phase 1 study testing 18F-SF12051 in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
18F-SF12051
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
2 Feb 2023to 30 Jan 2024
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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".
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  • 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.

Who cannot join

  • 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*.
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  • 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.
  • National Institute of Mental Health (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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: 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.

Read more

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.

Read the 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
Being tested
18F-SF12051
Keywords
PET Imaging, Neuroinflammation, Tspo
Medical subject headings
Neuroinflammatory Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-SF12051Drug

    Injected intravenously followed by PET scanning

Study groups in NCT05564429
Study groupRoleWhat they receive
High affinity binder (HAB) Translocator Protein (TSPO) genotypeExperimentalHealthy participants with HAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 \& 3 had whole body PET scan and phase 2 had brain PET scan.
Receives: Drug: 18F-SF12051
Low affinity binder (LAB) Translocator Protein (TSPO) genotypeExperimentalHealthy participants with LAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 \& 3 had whole body PET scan and phase 2 had brain PET scan.
Receives: Drug: 18F-SF12051
Mixed affinity binder (MAB) Translocator Protein (TSPO) genotypeExperimentalHealthy participants with MAB TSPO genotype receive 18F-SF12051 intravenously followed by whole body or brain positron emission tomography (PET) scan. Participants were randomized to either phase 1, 2, or 3. Phases 1 \& 3 had whole body PET scan and phase 2 had brain PET scan.
Receives: Drug: 18F-SF12051

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whole Body PET Uptake of [18F]SF12051 - Phase 1

    Participant received whole body PET scan and Uptake of [18F]SF12051 was measured using the Siemens Biograph mCT. Organ dosimetry was measured as microsieverts per mega-becquerel (uSv/MBq).

    Measured: Up to 120 minutes during the scan

  2. Brain PET Uptake of [18F]SF12051 - Phase 2

    Participant received brain PET scan and Uptake of [18F]SF12051 was measured using the Siemens Biograph mCT. Volume of distribution (Vt) was calculated via 2-Tissue-Compartment Model with plasma input function.

    Measured: Up to 120 minutes during the scan

  3. Whole Body PET Uptake of [18F]SF12051 - Phase 3

    Participant received whole body PET scan and Uptake of [18F]SF12051 was measured using the Siemens Biograph mCT. Organ dosimetry was measured as microsieverts per mega-becquerel (uSv/MBq).

    Measured: Up to 120 minutes during the scan

Secondary outcomes (4)

  1. Area Under the Organ Time-Activity Curves From 0-120 - Phase 1

    Biodistribution and dosimetry of [18F]SF12051 in healthy subjects was measured as area under the curve from 0-120 minutes shown as concentration of radioactivity reported as standard uptake values (SUV) x time during the course of the scans for each organ.

    Measured: Up to 120 minutes during the scan

  2. Area Under the Organ Time-Activity Curves From 0-120 - Phase 3

    Biodistribution and dosimetry of [18F]SF12051 in healthy subjects was measured as area under the curve from 0-120 minutes shown as concentration of radioactivity reported as standard uptake values (SUV) x time during the course of the scans for each organ.

    Measured: Up to 120 minutes during the scan

  3. Test-Retest Variability of [18F]SF12051

    Assess test-retest variability of [18F]SF12051 using absolute test-retest variability (aTRV).

    aTRV = | retest value - test value| / (test value + retest value) * 200%

    Measured: Up to 120 minutes during the scan

  4. Test-Retest Reliability of [18F]SF12051

    Assess test-retest reliability of [18F]SF12051 using intraclass correlation coefficient (ICC)

    ICC = (between-subject standard deviation)^2/[(between-subject standard deviation)^2 + (within-subject standard deviation)^2]

    Measured: Up to 120 minutes during the scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start2 Feb 2023
  3. Primary completion9 May 2023
  4. Study completion30 Jan 2024

Why it stopped: due to futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05564429
Sponsor's protocol ID
10000674
Other IDs
000674-M
Status last verified
Jan 2024
First submitted
29 Sep 2022
Last updated
9 Jul 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: .The results will be submitted to ClinicalTrials.gov

Publications

  • Yan X, Simeon FG, Liow JS, Morse CL, Jana S, Montero Santamaria JA, Jenkins M, Zoghbi SS, Pike VW, Innis RB, Zanotti-Fregonara P. [18F]SF51, a novel 18F-labeled PET radioligand for translocator protein 18kDa (TSPO) in brain, works well in monkeys but fails in humans. J Cereb Blood Flow Metab. 2025 Feb;45(2):365-372. doi: 10.1177/0271678X241304924. Epub 2024 Dec 9.

    PubMed 39654356

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 18F-SF12051 in people with Healthy, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole Body PET Uptake of [18F]SF12051 - Phase 1 (time frame: Up to 120 minutes during the scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05564429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.

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