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

NCT02379338 | Active Not Recruiting Phase 1

• 1 other identifier: 820959
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Dopamine D3 receptor

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Evaluate the safety of [18F]fluortriopride

  24 hours

Study Arms (2)

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.

Drug: [18F]Fluortriopride

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.

Drug: [18F]Fluortriopride

Interventions

[18F]Fluortriopride DRUG

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

Also known as: [18F]FTP

Biodistribution Cohort; Dynamic Brain Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be ≥ 18 years of age

You may not qualify if:

• 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.
• 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.
• Body Mass Index (BMI) \> 35
• 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.
• History of epilepsy or seizure disorder as assessed by medical record review and/or self-reported
• 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
• History of Post-Traumatic Stress Disorder (PTSD), bipolar disorder, schizophrenia or psychotic disorder as assessed by medical record review and/or self-reported
• 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
• Positive urine drug screen at the screening intake visit
• Self-reported current alcohol consumption that exceeds greater than 25 drinks per week
• 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
• Unwilling or unable to provide informed consent

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Related 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.

  PMID: 21132811 BACKGROUND

MeSH Terms

Interventions

16-fluoro-4-thiapalmitic acid

Study Officials

• Jacob Dubroff, MD, PhD

  Hospital of University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 4, 2015
• Study Start: January 1, 2015
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

US (1)