11C-ZTP-1 Imaging for Healthy Subjects
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo PET/CT scans with the study tracer [11C]ZTP-1, and some may have an MRI scan
Follow-up
Participants receive a follow-up call to check on their well-being after their PET/CT scans
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
All subjects will receive the same tests.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Mental Health (NIMH)
Lead Sponsor
Citations
[ 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 ...
4.
researchgate.net
researchgate.net/publication/391570899_11_CZTP-1_An_Effective_Short-Lived_Radioligand_for_PET_of_Rat_and_Monkey_Brain_Phosphodiesterase_Type_4_Subtype_B[ 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 ...
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