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| ID | Type | Description | Link |
|---|---|---|---|
| 2U01MH107803-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control - Test/Retest | Experimental | In Part 1 we will conduct a test/retest study of the novel GABA Transporter (GAT-1) imaging tracer [18F]GATT44 in humans, to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements |
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| Healthy Control - Test-Blocking | Experimental | In Part 2, we will conduct a test-blocking study to assess specific binding levels of [18F]GATT44 in humans. |
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| Healthy Control - Whole Body | Experimental | In Part 3, human dosimetry of [18F]GATT44 will be estimated by performing whole-body imaging studies |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [ 18F]GATT-44 | Drug | First in human radiotracer being evaluated in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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). | PET Day 1 and PET Day 2 |
| Whole body radiation dosimetry calculated from PET-CT images | Radiation absorbed doses of each organ will be calculated. | PET Scan Day 1 |
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Inclusion Criteria:
Exclusion:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannan Henry | Contact | +1 (203) 737-5278 | shannan.henry@yale.edu | |
| Kayla R Cottiers | Contact | 203-737-7496 | kayla.cottiers@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard E Carson, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University PET Center | Recruiting | New Haven | Connecticut | 06519 | United States |
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