[18F]GATT-44 PET scan to image the brain's GABA transporter (GAT-1).
Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
EARLY_PHASE1 · Yale University · NCT07457736
This will test whether the experimental PET tracer [18F]GATT-44 can safely image the brain's GAT-1 and how the tracer behaves in healthy adults.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07457736 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Healthy adults aged 18–60 who can give informed consent, are in good general health, are not pregnant or breastfeeding, and agree to the study's radiation and birth-control requirements are ideal candidates.
Not a fit: People seeking therapeutic benefit, children, pregnant or breastfeeding individuals, or those with significant medical conditions or excessive prior research radiation exposure are unlikely to gain direct benefit.
Why it matters
Potential benefit: If successful, it could provide a new imaging tool to measure GAT-1 in the human brain, aiding research into GABA-related disorders and supporting future diagnostic or therapeutic development.
How similar studies have performed: This is the first-in-human test of [18F]GATT-44 specifically, so its performance in people is unproven even though other PET tracers for related targets have been developed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Adult Participants, gatt44, experimental radiotracer, first in human radiotracer, GAT-1, GATT-44