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

NCT ID: NCT02379338

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2026-08-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dynamic Brain Cohort

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.

Group Type: EXPERIMENTAL

[18F]Fluortriopride

Intervention Type: DRUG

All subjects will receive a \[18F\]Fluortriopride PET/CT scan

Biodistribution Cohort

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.

Group Type: EXPERIMENTAL

[18F]Fluortriopride

Intervention Type: DRUG

All subjects will receive a \[18F\]Fluortriopride PET/CT scan

Interventions

[18F]Fluortriopride

All subjects will receive a \[18F\]Fluortriopride PET/CT scan

Intervention Type: DRUG

Other Intervention Names

[18F]FTP

Eligibility Criteria

Inclusion Criteria

1. Participants will be ≥ 18 years of age

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Dubroff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital of University of Pennsylvania

Locations

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21132811 (View on PubMed)

Other Identifiers

820959

Identifier Type: -

Identifier Source: org_study_id