24 Participants NeededMy employer runs this trial

18F-TPP for Membrane Potential Imaging

SH
KT
Overseen ByKristen Torres, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the body processes a new imaging agent called 18F-TPP, which helps visualize cell membrane potential (the electrical charge difference across a cell membrane) using PET scans. The goal is to develop new imaging methods that could enhance the understanding of various health conditions. Individuals who are generally healthy and can undergo PET scans without issues might be suitable candidates for this trial. 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.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anticoagulants (blood thinners) or if you cannot safely stop taking aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs).

What prior data suggests that 18F-TPP is safe for membrane potential imaging in humans?

Research shows that 18F-TPP, a substance used for imaging, is currently being tested for safety and effectiveness in people. Although specific information about 18F-TPP remains limited, similar substances with the same base element, Fluorine-18, have been safely used in other medical imaging studies. For instance, Fluorine-18 is often used in PET scans to detect cancer and other conditions and is generally well-tolerated.

Since this study is in its early stages, not all safety aspects of 18F-TPP are known. Early trials like this one aim to identify any side effects. Researchers will closely monitor the safety of 18F-TPP during the study to ensure it is safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the trial of 18F-TPP because it offers a novel approach to imaging membrane potential in human cells. Unlike traditional imaging methods, 18F-TPP is a PET imaging agent that specifically targets and visualizes the membrane potential (ΔΨT). This could lead to better understanding and diagnostics of various conditions related to cell membrane potential changes, such as heart and neurological diseases. By capturing detailed images of how cells function at a molecular level, this method may pave the way for more precise and effective treatments in the future.

What evidence suggests that 18F-TPP is effective for imaging membrane potential?

Research shows that 18F-TPP, the investigational treatment in this trial, is a promising tool for detecting changes in cell energy levels. Studies have found that it accurately senses when mitochondria, the cell's powerhouses, aren't functioning properly. This is important because mitochondrial problems are linked to many diseases. The radiotracer 18F-TPP detects signals from the cell's energy levels. Early research suggests it could help identify issues in tissues where cells are not functioning well or are dying. This makes 18F-TPP a potential breakthrough for diagnosing certain health conditions.56789

Who Is on the Research Team?

GE

Georges El Fakhri, PhD, DABR

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for healthy adults who are willing to follow study procedures and provide written consent. Participants must be in good overall health based on exams and lab tests. Women of childbearing age must use birth control during the study.

Inclusion Criteria

* Willing and able to give voluntary written informed consent
I am willing and able to follow all study procedures and be available for the study duration.
I am in good overall health based on recent medical tests.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Pharmacokinetics Assessment

Assessment of the pharmacokinetics of 18F-TPP using PET imaging, including potential arterial blood sampling for radioactivity analysis

Up to 90 days
Multiple visits for PET/CT and MRI scans

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-TPP

Trial Overview

The study is testing a new imaging method using a tracer called 18F-TPP with PET scans to map electrical activity in cells, focusing on how the tracer moves through the body.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: 18F-TPPExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

Citations

Membrane Potential-dependent Uptake of 18F ... - PMC

18 F-TPP is a promising new voltage sensor for detecting mitochondrial dysfunction and apoptosis in various tissues.

Construction and Preliminary Evaluation of Two 18 F-Labeled ...

Construction of 18 F-labeled PET MPI probe showed benefits to reduce the imaging cost, and enhance the image quality and patient-friendliness.

18F-TPP for Membrane Potential Imaging

In this study, investigators propose to use PET imaging to study the pharmacokinetics of 18F-TPP and develop methods for imaging membrane potential (ΔΨT) in ...

Membrane potential-dependent uptake of 18F ...

The present study suggests the potential power and unique advantages of 18F-TPP as a sensitive and accurate voltage sensor for detecting ...

Ultralow Dose PET Imaging of 18F-flurpiridaz

The radiotracer, 18F-flurpiridaz, is FDA-approved for detecting prostate cancer at standard doses. 18F-flurpiridaz is often found to be taken up at higher ...

F-18 (Fluorine-18) Radiation Safety Data

F-18 (Fluorine 18) Radiation Safety Data including half life, decay type and energy, external protection factors and internal (inhalation ...

tetrafluoroborate (18F--TFB), a PET probe for imaging sodium ...

It is safe to administer in humans and its biodistribution and dosimetry warrant further clinical evaluation as a PET tracer for imaging thyroid pathophysiology ...

SAFETY DATA SHEET Potential Health Effects

Physical and Chemical Properties. Boiling point: 100 ° Celsius (212°F). Melting point: 0° Celsius (32°F). Flashpoint. >200F. Radioactivity:.

Nuclide Safety Data Sheet Fluorine – 18

- Store 18F behind lead (Pb) shielding. - Use tools to indirectly handle unshielded sources and potentially contaminated vessels; avoid direct hand contact. - ...