Study of Radiotracer [18F]Fluortriopride ([18F]FTP) by PET/CT
- Conditions
- Healthy
- Registration Number
- NCT02379338
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Participants will be = 18 years of age<br><br> 2. Healthy volunteer is defined as being in good general health in the opinion of an<br> investigator (controlled diabetes, controlled hypertension or other well controlled<br> chronic medical conditions may be allowed at the discretion of an investigator if<br> they do not believe they will increase patient risk or interfere with the collection<br> of imaging data, specific excluded conditions are described under exclusion<br> criteria)<br><br> 3. Participants must be informed of the investigational nature of this study and<br> provide written informed consent in accordance with institutional and federal<br> guidelines prior to study-specific procedures.<br><br>Exclusion Criteria:<br><br> 1. Females who are pregnant at the time of screening will not be eligible for this<br> study, urine or blood pregnancy test will be performed in women of child-bearing<br> potential at screening.<br><br> 2. Body Mass Index (BMI) > 35<br><br> 3. Sustained uncontrolled hypertension (Systolic blood pressure greater than 160 mm Hg<br> and/or diastolic blood pressure greater than 110 mm Hg) at screening intake session.<br> If either of the pressure values is above the stated limits on the initial<br> assessment, blood pressure may be re-tested twice after initial assessment at five<br> minute intervals (for a total of 3 blood pressure assessments). The pressure<br> elevation is considered sustained if either the systolic or diastolic pressure<br> values are outside the stated limits for all three assessments, and the subject will<br> be excluded from study participation.<br><br> 4. History of epilepsy or seizure disorder as assessed by medical record review and/or<br> self-reported<br><br> 5. History of head trauma, that in the opinion of an investigator may interfere with<br> the uptake of [18F]FTP as assessed by medical record review and/or self-reported<br><br> 6. History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or<br> psychotic disorder as assessed by medical record review and/or self-reported<br><br> 7. Use of dopaminergic CNS stimulants (prescription, over-the counter or recreational<br> drugs) within 30 days of screening intake visit , as assessed by review of health<br> history form and concomitant medication review at screening intake visit (from<br> medical record and/or self-reported) that are deemed by a physician investigator to<br> have a potential influence on the binding of [18F]FTP<br><br> 8. Positive urine drug screen at the screening intake visit<br><br> 9. Self-reported current alcohol consumption that exceeds greater than 25 drinks per<br> week<br><br> 10. Any current medical condition, illness, or disorder as assessed by medical record<br> review and/or self-reported that is considered by a physician investigator to be a<br> condition that could compromise participant safety or successful participation in<br> the study<br><br> 11. Unwilling or unable to provide informed consent
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determine biodistribution of the radioactive investigational drug ([18F]fluortriopride) in healthy volunteers and calculate human dosimetry.;Demonstrate the feasibility of imaging the brain with the dopamine D3 receptor imaging agent [18F]fluortriopride
- Secondary Outcome Measures
Name Time Method Evaluate the safety of [18F]fluortriopride