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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 belowSelect...
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
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.
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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
2,009 Previous Clinical Trials
42,894,624 Total Patients Enrolled
Jacob Dubroff, MD, PhDPrincipal InvestigatorHospital of University of Pennsylvania
4 Previous Clinical Trials
310 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used any stimulants that affect the brain in the last 30 days.Eligibility Criteria), free from any clinically significant abnormalities on history, physical examination, or screening laboratory tests, and who has not used a tobacco product in the last six monthsMy doctor thinks I have a health issue that could make participating in the study unsafe for me.I am 18 years old or older.I have a history of epilepsy or seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Dynamic Brain Cohort
- Group 2: Biodistribution Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Who else is applying?
What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Hospital of the University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
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