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

Phase 1

Waitlist Available

Led By Jacob Dubroff, MD, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants will be ≥ 18 years of age

Be older than 18 years old

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial will use PET/CT imaging to study how a new radiotracer is taken up and metabolized by the body.

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

As this is an early-phase study primarily focused on tracking the radiotracer within the body rather than therapeutic effects, specific side effects are not detailed but may include reactions typical to PET/CT scan procedures such as discomfort at injection site or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of epilepsy or seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Demonstrate the feasibility of imaging the brain with the dopamine D3 receptor imaging agent [18F]fluortriopride

Determine biodistribution of the radioactive investigational drug ([18F]fluortriopride) in healthy volunteers and calculate human dosimetry.

Secondary study objectives

Evaluate the safety of [18F]fluortriopride

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dynamic Brain CohortExperimental Treatment1 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 CohortExperimental Treatment1 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.

0 / 2Eligibility criteria met