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

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Minor Re-verified, no change to tracked fields
  2. Minor Eligibility criteria expanded, about 20 words
    • Study description revised
  3. Minor Re-verified, no change to tracked fieldsv23
  4. Minor Start date changed from estimate of Jul 8, 2026 to Jul 1, 2026v22
  5. Minor Start date: Jul 7, 2026 to Jul 8, 2026v21
Show 19 earlier versionsHide 19 earlier versions
  1. Minor Start date: Jul 6, 2026 to Jul 7, 2026v20
  2. Minor Start date: Jul 5, 2026 to Jul 6, 2026v19
  3. Minor Start date: Jul 2, 2026 to Jul 5, 2026v18
  4. Minor Start date: Jul 1, 2026 to Jul 2, 2026v17
  5. Minor Start date: Jun 30, 2026 to Jul 1, 2026v16
  6. Minor Start date: Jun 29, 2026 to Jun 30, 2026v15
  7. Minor Start date: Jun 28, 2026 to Jun 29, 2026v14
  8. Minor Start date: Jun 24, 2026 to Jun 28, 2026v13
  9. Minor Start date: Jun 23, 2026 to Jun 24, 2026v12
  10. Minor Start date: Jun 22, 2026 to Jun 23, 2026v11
  11. Minor Start date: Jun 21, 2026 to Jun 22, 2026v10
  12. Minor Start date: Jun 18, 2026 to Jun 21, 2026v9
  13. Minor Start date: Jun 17, 2026 to Jun 18, 2026v8
  14. Minor Start date: Jun 16, 2026 to Jun 17, 2026v7
  15. Minor Start date: Jun 15, 2026 to Jun 16, 2026v6
  16. Minor Start date: Jun 14, 2026 to Jun 15, 2026
    • Eligibility criteria shortened, about 3 words
    v5
  17. Minor Start date: Jun 11, 2026 to Jun 14, 2026v4
  18. Minor Start date: Jun 10, 2026 to Jun 11, 2026v3
  19. Minor Start date: Jun 9, 2026 to Jun 10, 2026v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: PDE4B is a protein in cells that helps turn off certain chemical signals after they ve done their job. It controls inflammation, immune responses, and some brain signaling. Measuring PDE4B levels in the body can help doctors manage a disease or know if a treatment is working. Researchers want to find out if a new tracer (a radioactive substance injected during imaging scans) can help them measure PDE4B in people more effectively. Objective: To test a new tracer (\[11C\]ZTP-1) during imaging scans of the brain and body in healthy people. Eligibility: Healthy people aged 18 and older. They must have been screened under protocols 01M-0254 or 17M0181. Design: Participants will have either 1 or 2 clinic visits. During their first visit, all participants will have a positron emission tomography (PET)/computed tomography (CT) scan. Prior to the scan, they will have blood and urine tests and a test of their heart function. The study tracer will be given through a tube attached to a needle inserted into a vein in the arm. They will lie on a padded bed that fits inside a doughnut-shaped machine; the machine uses x-rays to create images of the inside of the body. Some participants will have a PET/CT scan of their whole body. They will need only 1 visit. The visit will last up to about 8 hours. Some participants will have a PET/CT scan of only their brain. They will also have a magnetic resonance imaging (MRI) scan of the brain. They may need to return for a second visit for the MRI scan. Participants will receive a follow-up call to check on their well-being after their PET/CT scans.
Trial Details
NCT Number NCT07625345
Lead Sponsor National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Healthy
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov