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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Evaluate the safety of [18F]fluortriopride

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 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,059 Total Patients Enrolled

Jacob Dubroff, MD, PhDPrincipal InvestigatorHospital of University of Pennsylvania

4 Previous Clinical Trials

310 Total Patients Enrolled

Media Library

[18F]Fluortriopride Clinical Trial Eligibility Overview. Trial Name: NCT02379338 — Phase 1

Healthy Subjects Research Study Groups: Dynamic Brain Cohort, Biodistribution Cohort

Healthy Subjects Clinical Trial 2023: [18F]Fluortriopride Highlights & Side Effects. Trial Name: NCT02379338 — Phase 1

[18F]Fluortriopride 2023 Treatment Timeline for Medical Study. Trial Name: NCT02379338 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has [18F]Fluortriopride been given formal authorization by the FDA?

"Due to the limited information on efficacy and safety, our team has assigned [18F]Fluortriopride a score of 1. This trial is currently in its first stage."

Answered by AI

Is the enrollment for this research project still open?

"The information posted on clinicaltrials.gov reveals that this trial is no longer enrolling participants, with the first posting dating back to January 1st 2015 and the last update occurring on August 3rd 2022. However, there are currently 840 other trials searching for candidates."

Answered by AI