Healthy
Conditions
Keywords
Dopamine D3 receptor
Brief summary
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).
Detailed description
\[18F\]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.
Interventions
DRUG[18F]Fluortriopride
All subjects will receive a \[18F\]Fluortriopride PET/CT scan
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants will be ≥ 18 years of age 2. "Healthy volunteer" is defined as being in good general health in the opinion of an investigator (controlled diabetes, controlled hypertension or other well controlled chronic medical conditions may be allowed at the discretion of an investigator if they do not believe they will increase patient risk or interfere with the collection of imaging data, specific excluded conditions are described under
Exclusion criteria
) 3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine biodistribution of the radioactive investigational drug ([18F]fluortriopride) in healthy volunteers and calculate human dosimetry. | 1 week | 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. |
| Demonstrate the feasibility of imaging the brain with the dopamine D3 receptor imaging agent [18F]fluortriopride | 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety of [18F]fluortriopride | 24 hours | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Dubroff, MD, PhD
Hospital of University of Pennsylvania
Outcome results
None listed