[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07457736":3,"trial-entities:NCT07457736":95,"trial-summary:NCT07457736":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":13,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":63,"locations":65,"central_contacts":88,"overall_officials":91,"references":93,"see_also_links":94},"NCT07457736","2000041030","Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1","RECRUITING","2030-01","2026-01","2026-08-20","2026-01-28","Yale University","OTHER",false,"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.",null,[18],"Healthy Adult Participants",[20,21,22,23,24],"gatt44","experimental radiotracer","first in human radiotracer","GAT-1","GATT-44","INTERVENTIONAL",[27],"EARLY_PHASE1",{"count":29,"type":30},32,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":40},"DRUG","[ 18F]GATT-44","First in human radiotracer being evaluated in this study.",[37,38,39],"Healthy Control - Test-Blocking","Healthy Control - Test\u002FRetest","Healthy Control - Whole Body",[41],"[18F]GAT44",[43,47,50],{"measure":44,"description":45,"timeFrame":46},"Test-Retest reproducibility calculations","Regional TACs are analyzed with kinetic models to generate regional volume of distribution (VT), using the metabolite-corrected arterial plasma concentrations over time as input function. Standardized uptake values (SUV) may also be generated.","PET Day 1 and PET Day 2",{"measure":48,"description":49,"timeFrame":46},"Specific binding levels of [18F]GATT44 in humans.","Binding potentials BPF, BPP, and BPND will be calculated from VT values, and reference models. White Matter will be the reference region to estimate nondisplaceable binding (VND).",{"measure":51,"description":52,"timeFrame":53},"Whole body radiation dosimetry calculated from PET-CT images","Radiation absorbed doses of each organ will be calculated.","PET Scan Day 1",[],"ALL","18 Years","60 Years",true,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"Inclusion Criteria:\n\n1. Willing and able to give voluntary written informed consent;\n2. 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;\n3. Male or female, aged 18 to 60, at screening;\n4. In good general health as evidenced by medical history, physical examination, ECG, serum\u002Furine biochemistry, hematology, and serology tests;\n5. 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).\n\nExclusion:\n\n1. Less than 18 years of age;\n2. Pregnant or breastfeeding;\n3. Any significant systemic illness or unstable medical condition;\n4. Pre-existing medical conditions or claustrophobic reactions;\n5. Research-related radiation exposure exceeds current PET Center guidelines;\n6. History of a bleeding disorder or are currently taking anticoagulants.",[64],"ADULT",[66],{"facility":67,"status":7,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":85},"Yale University PET Center","New Haven","Connecticut","06519","United States",[73,78,82],{"name":74,"role":75,"phone":76,"email":77},"Shannan Henry","CONTACT","+1 (203) 737-5278","shannan.henry@yale.edu",{"name":79,"role":75,"phone":80,"email":81},"Kayla R Cottiers","203-737-7496","kayla.cottiers@yale.edu",{"name":83,"role":84},"Richard E Carson, PhD","PRINCIPAL_INVESTIGATOR",{"lat":86,"lon":87},41.30815,-72.92816,[89,90],{"name":74,"role":75,"phone":76,"email":77},{"name":79,"role":75,"phone":80,"email":81},[92],{"name":83,"affiliation":12,"role":84},[],[],{"nct_id":4,"conditions":96,"biomarkers":98},[97],"Healthy",[],{"nct_id":4,"found":58,"summary":100,"prompt_version":110},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an interventional study planning to enroll 32 healthy adult participants. It is not specified if it is randomized or blinded.","completed","Evaluating [18F]GATT-44 for Brain Imaging","This study is evaluating a new imaging agent called [18F]GATT-44. Researchers want to understand how it moves through the body, how it's processed, and how well it binds to specific targets in the brain. They will also check if the imaging results are consistent over time. This study is looking for healthy adults between 18 and 60 years old. Success will be measured by how consistently [18F]GATT-44 binds in the brain and by understanding its radiation dose. The current recruitment status is unclear.","The primary endpoints are measured at PET Day 1 and PET Day 2, and for whole-body radiation dosimetry on PET Scan Day 1.",83,"You would undergo PET scans on two separate days to measure binding and reproducibility. Whole-body PET-CT images will also be taken on one of these days.","Not stated in the trial record.",[],"v2"]