Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [ 18F]GATT-44.
- Who it may be relevant to
- Registry conditions: Healthy Adult Participants. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Evaluate \[18F\]GATT-44 (aka \[18F\]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of \[18F\]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of \[18F\]GATT-44 by performing whole-body imaging studies.
Interventions
- Drug [ 18F]GATT-44
First in human radiotracer being evaluated in this study.
Primary outcome measures
- Test-Retest reproducibility calculations [Time frame: PET Day 1 and PET Day 2]
- Specific binding levels of [18F]GATT44 in humans. [Time frame: PET Day 1 and PET Day 2]
- Whole body radiation dosimetry calculated from PET-CT images [Time frame: PET Scan Day 1]
Eligibility criteria
Inclusion criteria
- Willing and able to give voluntary written informed consent;
- 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;
- Male or female, aged 18 to 60, at screening;
- In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests;
- 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:
- Less than 18 years of age;
- Pregnant or breastfeeding;
- Any significant systemic illness or unstable medical condition;
- Pre-existing medical conditions or claustrophobic reactions;
- Research-related radiation exposure exceeds current PET Center guidelines;
- History of a bleeding disorder or are currently taking anticoagulants.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Yale University PET Center — New Haven
Identifiers
NCT: NCT07457736 · 2000041030 · 2U01MH107803-06