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.

Study Overview

• Status: Not yet recruiting
• Conditions: Membrane Potential Mapping
• Intervention / Treatment: Drug: 18F-TPP

Detailed Description

The aims of this study are:

1. Assessment of the pharmacokinetics of primed constant infusion of 18F-TPP in humans.
2. Assessment of normal variation of membrane potential (ΔΨT) and extracellular space (ECS) in a cohort of "normal" subjects.
3. 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shannan Henry; Phone Number: (203) 737-5278; Email: shannan.henry@yale.edu
• Study Contact Backup: Name: Kristen Torres, BS; Phone Number: 203-785-4799; Email: kristen.torres@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University PET Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-TPP; PET imaging to study the pharmacokinetics of 18F-TPP and develop methods for imaging membrane potential (ΔΨT) in humans. 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.	Drug: 18F-TPP; radiotracer specific for imaging mitochondrial membrane potential (ΔΨm) administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracers volume of distribution (VT)	Maps of the 18F-TPP tracer volume of distribution (VT) and ΔΨT based on quantitative analysis of PET imaging.	Visit 2 (up to 90 days post screening visit 1)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Georges El Fakhri, PhD, DABR, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): August 1, 2033

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2000039939; 7P41EB022544-08 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No