[18F]GATT-44 PET scan to image the brain's GABA transporter (GAT-1).

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 early-phase, first-in-human protocol gives a small dose of the experimental PET radiotracer [18F]GATT-44 to healthy adult volunteers to characterize pharmacokinetics, metabolism, and in vivo binding to GAT-1. Participants will undergo brain PET scans, a test-block session to determine specific binding, and whole-body scans to estimate radiation dosimetry. The study includes repeat scans to assess reproducibility of kinetic and binding parameters. Safety monitoring includes medical history, physical exam, ECG, and laboratory testing before and after imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing and able to give voluntary written informed consent;
2. Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff;
3. Male or female, aged 18 to 60, at screening;
4. In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests;
5. Females of childbearing potential, and male subjects, must be willing to practice birth control for the duration of the study (unless medical documentation is provided confirming subject is permanently sterile).

Exclusion:

1. Less than 18 years of age;
2. Pregnant or breastfeeding;
3. Any significant systemic illness or unstable medical condition;
4. Pre-existing medical conditions or claustrophobic reactions;
5. Research-related radiation exposure exceeds current PET Center guidelines;
6. History of a bleeding disorder or are currently taking anticoagulants.

Where it's running

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

Study contacts

• Principal investigator: Richard E Carson, PhD — Yale University
• Study coordinator: Shannan Henry
• Email: shannan.henry@yale.edu
• Phone: +1 (203) 737-5278

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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.