PET/CT Imaging with [18F]Fluortriopride in Healthy Subjects

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Pennsylvania

Must not be taking: Dopaminergic stimulants

Disqualifiers: Pregnancy, BMI > 35, Epilepsy, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

29 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use dopaminergic CNS stimulants (drugs affecting the brain's dopamine system) within 30 days of the screening visit.

Is [18F]Fluortriopride safe for humans?

Research on [18F]Fluortriopride in animals suggests it is generally safe, with the highest radiation dose affecting the gallbladder in primates. This data helps estimate human safety, but more studies in humans are needed to confirm. ^{1 2 3 4 5}

How is the drug [18F]Fluortriopride unique compared to other treatments?

[18F]Fluortriopride is unique because it is a PET imaging agent that specifically targets dopamine D3 receptors, which can help in investigating neuropsychiatric disorders like Parkinson's disease, dystonia, and schizophrenia. This specificity for D3 receptors distinguishes it from other imaging agents that may target different receptors or transporters. ^{1 2 3 6 7}

Research Team

Jacob Dubroff, MD, PhD

Principal Investigator

Hospital of University of Pennsylvania

Eligibility Criteria

This trial is for healthy adults over 18, possibly with well-controlled chronic conditions like diabetes or hypertension. Pregnant women, individuals with a BMI over 35, uncontrolled high blood pressure, epilepsy, severe head trauma history, heavy alcohol use (>25 drinks/week), certain mental health disorders (like PTSD or schizophrenia), or recent use of dopaminergic stimulants cannot participate.

Inclusion Criteria

"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)

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

I haven't used any stimulants that affect the brain in the last 30 days.

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

Positive urine drug screen at the screening intake visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dynamic Brain Imaging

Participants undergo a dynamic brain [18F]Fluortriopride PET/CT scan over approximately 2 hours and a research brain MRI on a separate day

1 week

2 visits (in-person)

Biodistribution Imaging

Participants undergo a series of whole body biodistribution [18F]Fluortriopride PET/CT scans over approximately 4 hours

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

1 week

Treatment Details

Interventions

• [18F]Fluortriopride

Trial Overview [18F]Fluortriopride ([18F]FTP) is being tested to see how it's distributed in the body and how it's broken down and removed when used in PET/CT scans. This phase 1 pilot study will help understand [18F]FTP's behavior inside the human body using imaging technology.

Participant Groups

Group I: Dynamic Brain Cohort Experimental Treatment 1 Intervention

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 II: Biodistribution Cohort Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[18F]CFT synthesis and binding to monoamine transporters in rats. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Absorbed radiation dosimetry of the D3-specific PET radioligand [18F]FluorTriopride estimated using rodent and nonhuman primate. [2020]

3. Italy pubmed.ncbi.nlm.nih.gov

Imaging of dopamine transporter with [18F]LBT-999: initial evaluation in healthy volunteers. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[18F]Fluorinated estradiol derivatives for oestrogen receptor imaging: impact of substituents, formulation and specific activity on the biodistribution in breast tumour-bearing mice. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Tissue distribution of radioiodinated FAUC113: assessment of a pyrazolo(1,5-a) pyridine based dopamine D4 receptor radioligand candidate. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Shortening the Scan Duration on Quantitative Accuracy of [18F]Flortaucipir Studies. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Quantitative ex vivo and in vitro receptor autoradiography using 11C-labeled ligands and an imaging plate: a study with a dopamine D2-like receptor ligand [11C]nemonapride. [2019]