Study of Radiotracer [18F]Fluortriopride ([18F]FTP) by PET/CT

Healthy Clinical Trial

Official title:

Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluotriopride ([18F]FTP) by PET/CT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02379338
• Other study ID #: 820959
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

1. Females who are pregnant at the time of screening will not be eligible for this study, urine or blood pregnancy test will be performed in women of child-bearing potential at screening.

2. Body Mass Index (BMI) > 35

3. Sustained uncontrolled hypertension (Systolic blood pressure greater than 160 mm Hg and/or diastolic blood pressure greater than 110 mm Hg) at screening intake session. If either of the pressure values is above the stated limits on the initial assessment, blood pressure may be re-tested twice after initial assessment at five minute intervals (for a total of 3 blood pressure assessments). The pressure elevation is considered sustained if either the systolic or diastolic pressure values are outside the stated limits for all three assessments, and the subject will be excluded from study participation.

4. History of epilepsy or seizure disorder as assessed by medical record review and/or self-reported

5. History of head trauma, that in the opinion of an investigator may interfere with the uptake of [18F]FTP as assessed by medical record review and/or self-reported

6. History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or psychotic disorder as assessed by medical record review and/or self-reported

7. Use of dopaminergic CNS stimulants (prescription, over-the counter or recreational drugs) within 30 days of screening intake visit , as assessed by review of health history form and concomitant medication review at screening intake visit (from medical record and/or self-reported) that are deemed by a physician investigator to have a potential influence on the binding of [18F]FTP

8. Positive urine drug screen at the screening intake visit

9. Self-reported current alcohol consumption that exceeds greater than 25 drinks per week

10. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

11. Unwilling or unable to provide informed consent

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• [18F]Fluortriopride
All subjects will receive a [18F]Fluortriopride PET/CT scan

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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