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In this phase 1 pilot study, positron emission tomography (PET/CT) imaging will be used to determine the biodistribution, metabolism and excretion of a novel radiotracer [18F]Fluortriopride ([18F]FTP).
[18F]FTP is a novel radioactive tracer that has shown potential in labeling dopamine D3 receptors through PET/CT imaging. This is a phase 1 study design meant to evaluate safety, biodistribution and brain uptake of [18F]FTP in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Brain Cohort | Experimental | The Dynamic Brain cohort will include up to 10 patients who will undergo a dynamic brain [18F]Fluortriopride PET/CT scan over a period of approximately 2 hours. Subjects in this cohort will also undergo a research brain MRI, generally on a separate day from the PET/CT. |
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| Biodistribution Cohort | Experimental | The Biodistribution cohort will include up to10 patients who will undergo a series of whole body biodistribution [18F]Fluortriopride PET/CT scans over a period of approximately 4 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Fluortriopride | Drug | All subjects will receive a [18F]Fluortriopride PET/CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine biodistribution of the radioactive investigational drug ([18F]fluortriopride) in healthy volunteers and calculate human dosimetry. | Assessing the biodistribution of the radioactive investigational drug ([18F]fluortriopride) and calculation of human dosimetry in healthy volunteers are completed with MRI results from Dynamic Brain cohort, PET/CT results and laboratory results. | 1 week |
| Demonstrate the feasibility of imaging the brain with the dopamine D3 receptor imaging agent [18F]fluortriopride | Participants will complete an anatomical MRI scan on an MRI scanner (without contrast) to enable precise anatomic location of the PET scan results. MRI and PET images will be co-registered so that the anatomical structures observed on the MRI can be accurately outlined on the PET scans for analysis. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of [18F]fluortriopride | Safety of the radioactive investigational drug ([18F]fluortriopride) as measured by the number of participants with adverse events and significant changes in laboratory and/or PET/CT results. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Dubroff, MD, PhD | Hospital of University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21132811 | Background | Mach RH, Tu Z, Xu J, Li S, Jones LA, Taylor M, Luedtke RR, Derdeyn CP, Perlmutter JS, Mintun MA. Endogenous dopamine (DA) competes with the binding of a radiolabeled D(3) receptor partial agonist in vivo: a positron emission tomography study. Synapse. 2011 Aug;65(8):724-32. doi: 10.1002/syn.20891. Epub 2011 Mar 21. |
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| ID | Term |
|---|---|
| C515150 | 16-fluoro-4-thiapalmitic acid |
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