Membrane potential mapping with a radioactive PET tracer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study uses PET/CT to characterize the pharmacokinetics of 18F-TPP under primed constant infusion and bolus injection, and to explore normal variation in membrane potential (ΔΨT) and extracellular space. The protocol may include arterial blood sampling to track radioactivity in blood, plasma, and metabolites. An MRI will be collected separately, and scans will be performed at Yale PET Center with support from NIBIB. Eligible participants are in good health and must meet safety criteria, including MRI compatibility and contraception requirements for those of childbearing potential.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to give voluntary written informed consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry and hematology tests.
* If female of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study.

Exclusion Criteria:

* Know structural heart disease (e.g. myocardial infarction)
* Abnormal and clinically significant ECG (as determined by the Investigator or his/her designee) at screening.
* Laboratory tests with clinically significant abnormalities at screening
* Pregnancy or Lactation
* MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects/fragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).
* Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits followed by the Yale University PET Center.
* Subject who has current, past, or anticipated exposure to radiation in the workplace within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
* Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
* Arterial Line Exclusion: Blood donation within eight weeks of the start of the study.
* Arterial Line Exclusion: History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
* Arterial Line Exclusion: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) greater than 5msec above the upper limit of normal.
* Arterial Line Exclusion: Unable to safely discontinue or hold aspirin and other NSAID use

Where it's running

• Yale University PET Center
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Georges El Fakhri, PhD, DABR — Yale University
• Study coordinator: Shannan Henry
• Email: shannan.henry@yale.edu
• Phone: (203) 737-5278

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pet imaging of sigma1 receptors in healthy adults

  This study tests two sigma-1 radiotracers, to see how well they image the brain in healthy adults and how reliably the imaging measurements work.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07915323

• Intradermal Flu Vaccine After All: Watching Immune Response in Skin and Blood

  This study tests whether giving the seasonal flu shot into the skin (instead of muscle) changes the immune response in healthy adults, cancer patients about to start immunotherapy, and people with post-acute infection syndromes.

  Recruiting Early Phase 1 Yale University · New Haven, Connecticut · NCT07908329

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07800520

• Greater Occipital Nerve Blockade for Veterans with Post-Traumatic Headache

  This study tests whether injecting tiny amounts of anesthesia into the greater occipital nerve can reduce headache days for veterans with chronic post-traumatic headaches.

  Recruiting Phase 2 Yale University · West Haven, Connecticut · NCT07796074

• Adaptive Decision Support for Addiction Treatment: Testing a Care Tool for ED Doctors to Help Buprenorphine Use

  We’re testing a refined decision-support tool in emergency departments to help doctors prescribe buprenorphine to adults with moderate to severe opioid use disorder.

  Recruiting at 3 sites Yale University · Guilford, Connecticut and 2 other locations · NCT07793383

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.