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Evaluating [11C]ZTP-1 for Imaging PDE4B

This study is testing a new tracer called [11C]ZTP-1. Researchers want to see if this tracer can help them measure a protein called PDE4B in the brain and body of healthy people. PDE4B helps control inflammation and brain signals. By measuring PDE4B levels, doctors might better understand diseases or see if treatments are working. The main goal is to see how much [11C]ZTP-1 is taken up by the brain and to measure PDE4B density. You can join if you are a healthy person aged 18 or older and have been screened under specific protocols. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 40 healthy participants. It is designed to evaluate the ability of [11C]ZTP-1 to localize and measure PDE4B.
What's involved
Participants will receive an injection of 11C-ZTP-1, followed by PET scanning. You will have either 1 or 2 clinic visits.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Total Volume of Distribution, is measured at 120 minutes. Other follow-up details are not specified.

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NCT07625345

Evaluation of [11C]ZTP-1 to Image PDE4B

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
National Institute of Mental Health (NIMH)
~40 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:11C-ZTP-1

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Volume of Distribution
Measured over 120 minutes

Conditions

Healthy

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Robert B Innis, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Mental Health (NIMH)

Who to contact

Tara N Turon, C.R.N.P.
[email protected]
(301) 827-6599
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 18 years or older.
Must have undergone a screening assessment under protocol 01M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Participants or protocol 17M0181 Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies."
Be healthy based on medical history, physical examination, and laboratory testing.
Able to provide informed consent.
Willingness to complete all study procedures including MRI tests.
Have had 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

Exclusion

Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).
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) that, 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).
HIV infection.
Pregnancy or breastfeeding.
Must not have substance use disorder or alcohol use disorder.
Unable to travel to the NIH.
Unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.
Known hypersensitivity to phosphodiesterase-4 (PDE-4) inhibitors (e.g. apremilast, roflumilast, nerandomilast, crisborole).
Taking CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, erythromycin, ritonavir); CYP3A4 inducers (e.g. phenobarbital St. John's Wort, rifampicin) or oral contraceptives containing gestodene and ethinyl estradiol.

What this trial measures

  • Total Volume of Distribution120 minutes

    Quantification of 11C-ZPT-1