40 Participants NeededMy employer runs this trial

11C-ZTP-1 Imaging for Healthy Subjects

TN
RB
Overseen ByRobert B Innis, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Mental Health (NIMH)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tracer called 11C-ZTP-1, which helps researchers measure a protein linked to inflammation and brain signaling. The goal is to determine if this tracer can provide clear images of the brain and body using advanced scanning methods. It is designed for healthy individuals who have already been screened under specific criteria. Participants will undergo imaging scans, such as PET/CT scans, to assess the tracer's effectiveness. As a Phase 1 trial, this research focuses on understanding how the tracer functions in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants taking CYP3A4 inhibitors (like grapefruit juice or certain antibiotics) and CYP3A4 inducers (like St. John's Wort).

What prior data suggests that this tracer is safe for use in humans?

Research has shown that the tracer 11C-ZTP-1, used in imaging scans, has not been linked to significant health risks in people. Available safety data does not report any side effects directly caused by 11C-ZTP-1, suggesting it is generally safe. However, as this is an early-stage trial, the treatment remains under careful study to ensure safety. Researchers will closely monitor participants for any side effects during and after the imaging procedures.12345

Why are researchers excited about this trial?

Unlike traditional imaging methods that rely on established tracers, 11C-ZTP-1 is unique because it uses a novel radioactive tracer designed to provide more precise brain imaging. Researchers are excited about this treatment because it targets specific brain receptors with potentially higher accuracy and less background noise, which could improve the clarity and reliability of brain scans. This advancement might lead to better diagnosis and understanding of brain conditions compared to current standard imaging techniques.

What evidence suggests that this tracer is effective for measuring PDE4B levels?

Research has shown that [11C]ZTP-1 effectively images a protein called PDE4B in the brain. Studies in rats and monkeys demonstrated that this tracer provides a clear signal specific to PDE4B, with minimal interference from other substances. This clarity is crucial for understanding the protein's role in inflammation and brain function. The tracer exhibited high activity and low contamination, making it promising for accurate brain imaging. These findings suggest that [11C]ZTP-1 could be a valuable tool for studying diseases related to PDE4B. In this trial, all subjects will undergo the same tests using [11C]ZTP-1 to further evaluate its imaging capabilities in healthy humans.12678

Who Is on the Research Team?

RB

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 and older who have already been screened in specific earlier studies. Participants should not have any major health issues.

Inclusion Criteria

Willingness to complete all study procedures including MRI tests
Must have undergone a screening assessment under protocol 01M-0254 or protocol 17M0181
Be healthy based on medical history, physical examination, and laboratory testing
See 4 more

Exclusion Criteria

Known hypersensitivity to phosphodiesterase-4 (PDE-4) inhibitors
Clinically significant abnormalities on EKG or laboratory testing including CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen)
History of neurologic illness or injury affecting study data interpretation
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Not specified

Imaging

Participants undergo PET/CT scans with the study tracer [11C]ZTP-1, and some may have an MRI scan

1-2 visits
1-2 visits (in-person)

Follow-up

Participants receive a follow-up call to check on their well-being after their PET/CT scans

Not specified

What Are the Treatments Tested in This Trial?

Interventions

  • 11C-ZTP-1

Trial Overview

The study is testing a new imaging tracer called [11C]ZTP-1 to see if it can help measure levels of the protein PDE4B in the brain and body using PET/CT scans. Some participants may also get an MRI scan.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: One-armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials
3,007
Recruited
2,852,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40341096/

[ 11 C]ZTP-1: An Effective Short-Lived Radioligand for PET of ...

[11C]ZTP-1 was obtained in a high activity yield and with high molar activity. Rat and monkey PET imaging showed high whole-brain radioactivity ...

[11C]ZTP-1, an Effective Shorter-lived Radioligand for PET ...

[11C]ZTP-1 is also effective for imaging PDE4B in rat brain, with a high PDE4B-specific signal and negligible radiometabolite contamination.

[11C]ZTP-1: An Effective Short-Lived Radioligand for PET of ...

Results: [11C]ZTP-1 was obtained in a high activity yield and with high molar activity. Rat and monkey PET imaging showed high whole-brain ...

[ 11 C]ZTP-1: An Effective Short-Lived Radioligand for PET ...

[11C]ZTP-1 showed less than 1% radiometabolite contamination at 30 min. This effect persisted at 2 hours, peaked at 4 hours, and diminished at 6 hours and 24 ...

[11C]ZTP-1: An Effective Short-Lived Radioligand for PET of ...

[11C]ZTP-1: An Effective Short-Lived Radioligand for PET of Rat and Monkey Brain Phosphodiesterase. Figures & Data Supplemental Info & Metrics ...

Safety Data Sheet

Hazards not otherwise classified. There are no adverse physical or health effects known that are not covered by the hazard classes of the.

SAFETY DATA SHEET

Precautionary Statements. Prevention. Wash face, hands and any exposed skin thoroughly after handling. Do not eat, drink or smoke when using this product.

SAFETY DATA SHEET

Long term exposure to acid fumes may cause damage to teeth, bronchial irritation, chronic cough, bronchial pneumonia, and gastrointestinal ...