Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07506616

Membrane Potential Mapping with18F-TPP

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 humans.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University PET Center

New Haven, Connecticut, 06510, United States

About this study

The aims of this study are:

  • Assessment of the pharmacokinetics of primed constant infusion of 18F-TPP in humans.
  • Assessment of normal variation of membrane potential (ΔΨT) and extracellular space (ECS) in a cohort of "normal" subjects.
  • Assessment of the pharmacokinetics of bolus injection of 18F-TPP in humans. Studies will be performed on a PET/CT scanner. A separate MRI will be collected.

Each scan may or may not have arterial blood sampling for measurement of the time course of radioactivity in the whole-blood, plasma and radiometabolite analysis on selected plasma samples.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to give voluntary written informed consent
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • In good general health as evidenced by medical history, physical examination, ECG, serum/urine biochemistry and hematology tests.
  • If female of childbearing potential, must agree to use an acceptable method of birth control, as determined by the principal investigator, for the duration of the study.

Exclusion criteria

  • Know structural heart disease (e.g. myocardial infarction)
  • Abnormal and clinically significant ECG (as determined by the Investigator or his/her designee) at screening.
  • Laboratory tests with clinically significant abnormalities at screening
  • Pregnancy or Lactation
  • MRI incompatible implants (i.e., such as pacemaker, artificial joints, non-removable body piercings) and other contraindications for MRI, such as claustrophobia, having implanted or embedded metal objects/fragments or fragments in the head or body that would present a risk during the MRI scanning procedure, or have worked with ferrous metals either as a vocation or hobby (for example, as a sheet metal worker, welder, or machinist).
  • Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits followed by the Yale University PET Center.
  • Subject who has current, past, or anticipated exposure to radiation in the workplace within one year of the proposed research scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits.
  • Has any condition that, in the opinion of the investigator, would prevent compliance with the study protocol.
  • Arterial Line Exclusion: Blood donation within eight weeks of the start of the study.
  • Arterial Line Exclusion: History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto).
  • Arterial Line Exclusion: Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) greater than 5msec above the upper limit of normal.
  • Arterial Line Exclusion: Unable to safely discontinue or hold aspirin and other NSAID use

Treatment and study plan

18F-TPP

Drug

radiotracer specific for imaging mitochondrial membrane potential (ΔΨm) administered intravenously

Primary outcomes

  1. Tracers volume of distribution (VT)

    Time frame: Visit 2 (up to 90 days post screening visit 1)

    Maps of the 18F-TPP tracer volume of distribution (VT) and ΔΨT based on quantitative analysis of PET imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen Torres, BS

CONTACT

[email protected]

203-785-4799

Shannan Henry

CONTACT

[email protected]

(203) 737-5278

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Apr 1, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.