Actively Recruiting
Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
Led by Yale University · Updated on 2026-04-06
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating [18F]GATT-44, a new radiotracer, to study its behavior and reliability in imaging the GABA Transporter-1 using positron emission tomography (PET). This early phase 1 trial aims to understand how the tracer moves, binds, and is metabolized in healthy adult participants, and to measure its reproducibility and safety using whole-body imaging. The study consists of three parts: first, a test/retest phase to examine the tracer's pharmacokinetics and reproducibility of measurements; second, a test-blocking phase to assess specific binding of [18F]GATT-44 in humans; and third, a whole-body imaging phase to estimate radiation dosimetry. Participants in each part will undergo PET scans to collect this data. Participants will be healthy adults aged 18 to 60 who provide informed consent and meet health requirements. They will receive the investigational tracer during PET scan sessions, with evaluations including medical history, physical exams, ECG, laboratory tests, and imaging assessments. The primary outcomes include reproducibility measurements, specific binding levels, and radiation dosimetry from PET scans. The study involves multiple visits and monitoring to ensure participant safety and accurate data collection.
CONDITIONS
Brief Title
Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to give voluntary written informed consent
- Able to read and write, communicate effectively, and follow all study requirements
- Male or female aged 18 to 60 years at screening
- In good general health based on medical history, physical exam, ECG, and lab tests
- Females of childbearing potential and males must agree to use birth control unless permanently sterile
You will not qualify if you...
- Under 18 years of age
- Pregnant or breastfeeding
- Any significant systemic illness or unstable medical condition
- Pre-existing medical conditions or claustrophobia
- Research-related radiation exposure exceeding PET Center guidelines
- History of bleeding disorders or currently taking anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 days depending on study part
Participants undergo PET imaging using the novel radiotracer [18F]GATT-44 to evaluate its pharmacokinetic behavior, binding levels, or dosimetry depending on the study part.
1 to 2 PET scan visits depending on study part
Trial Site Locations
Total: 1 location
1
Yale University PET Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
S
Shannan Henry
K
Kayla R Cottiers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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