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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a new imaging agent, [18F]Fluortriopride, moves and is processed in the body using PET/CT scans. The study consists of two parts: one focuses on brain scans, and the other on whole-body scans. It seeks healthy volunteers without issues like uncontrolled high blood pressure or a history of seizures. Participants will help researchers understand the potential of this agent for future medical imaging.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

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.

What prior data suggests that [18F]Fluortriopride is safe for PET/CT imaging?

Research on [18F]Fluortriopride, a new imaging agent, has shown it to be generally safe in animals. Studies found the highest radiation levels in the gallbladder of primates, indicating good tolerance of the treatment.

In humans, safety information is still being collected. Early studies focus on how the body processes the tracer and its effects on the brain. Researchers closely monitor for any side effects. As this is a phase 1 trial, the primary goal is to ensure safety, so participants receive careful observation for any negative reactions. This process helps ensure the treatment's safety for future use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of [18F]Fluortriopride in PET/CT imaging because it offers a new way to visualize brain and body functions with high precision. Unlike traditional imaging agents, [18F]Fluortriopride can provide dynamic images of the brain, allowing for a detailed look at how brain activity evolves over time. Additionally, its ability to map the biodistribution throughout the entire body offers comprehensive insights into how the compound travels and affects different tissues. This innovative approach could lead to better diagnostic capabilities, potentially enhancing how we understand various neurological and systemic conditions.

What evidence suggests that [18F]Fluortriopride is effective for PET/CT imaging?

Research on [18F]Fluortriopride has shown it to be generally safe based on animal studies. These studies identified the gallbladder in primates as the main area affected by radiation, though the impact was not severe. [18F]Fluortriopride is a specialized substance that aids doctors in visualizing bodily movements through imaging. Early tests in animals and non-human subjects demonstrated that this substance spreads well throughout the body, which is crucial for obtaining clear images. In this trial, participants will be divided into two groups: the Dynamic Brain Cohort, which will undergo a dynamic brain [18F]Fluortriopride PET/CT scan, and the Biodistribution Cohort, which will undergo a series of whole-body biodistribution [18F]Fluortriopride PET/CT scans. The goal is to understand how the body processes it, aiding in the exploration of its potential for future medical use. ^{1 2 4 6 7}

Who Is on the Research Team?

Jacob Dubroff, MD, PhD

Principal Investigator

Hospital of University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-1-2015-0fd23

PET/CT Imaging with [18F]Fluortriopride in Healthy Subjects Research on [18F]Fluortriopride in animals suggests it is generally safe, with the highest radiation dose affecting the gallbladder in primates. This data helps ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02379338

Study of Radiotracer [18F]Fluortriopride ([18F]FTP) by PET ... This is a phase 1 study design meant to evaluate safety, biodistribution and brain uptake of [18F]FTP in healthy volunteers.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6174116/

Validation of gallbladder absorbed radiation dose ... [18F]Fluortriopride PET dosimetry simulations and experimentally validated results confirm a significant reduction in gallbladder radiation dose ...

4. ctv.veeva.com ctv.veeva.com/study/study-of-radiotracer-18f-fluortriopride-18f-ftp-by-pet-ct

Study of Radiotracer [18F]Fluortriopride ([18F]FTP) by PET/CT This is a phase 1 study design meant to evaluate safety, biodistribution and brain uptake of [18F]FTP in healthy volunteers.

5. e-century.us e-century.us/files/ajnmmi/6/6/ajnmmi0039650.pdf

specific PET radioligand [18F]FluorTriopride estimated ... Here we estimate hu- man radiation dosimetry for [18F]FTP based on the ex-vivo biodistribution in rodents and in vivo distribution in nonhu- man ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6771272/

18F‑AlF Labeled Peptide and Protein Conjugates as ... Fused PET and CT images were consistent with the biodistribution data, i.e. ... Safety data included vital signs, physical examination, ECG, laboratory ...

7. trial.medpath.com trial.medpath.com/clinical-trial/35b828040fbb3046/nct07110519-pet-contrast-agent-18f-fluoromannitol

Positron Emission Tomography (PET) Contrast Agent Kinetics and ... The primary objective of this study is to generate safety data in healthy adult human volunteers. In the future, this tracer may help to determine if a medical ...