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RecruitingNCT07506616Updated Aug 31, 2026

Membrane Potential Mapping with18F-TPP

A Phase 1 interventional study of 18F-TPP in Membrane Potential Mapping, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Yale University · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
21 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Membrane Potential Mapping
03

In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • 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

Interventions

  • Drug18F-TPP

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

06

What researchers measure

Primary outcomes

  1. Tracers volume of distribution (VT)

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

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

07

Study locations

1 of 1 sites recruiting
  • Yale University PET Center
    New Haven, Connecticut 06510, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07506616
Lead sponsor
Yale University
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Responsible party
Georges El Fakhri (Professor of Radiology and Biomedical Imaging, Therapeutic Radiology and of Biomedical Informatics, Yale University) — Principal investigator
First posted
Apr 1, 2026
Start date
Aug 2026 (estimated)
Primary completion
Aug 2033 (estimated)
Completion
Aug 2033 (estimated)
Last update
Aug 31, 2026

Study contacts

Shannan Henry
Contact
shannan.henry@yale.edu
(203) 737-5278
Kristen Torres, BS
Contact
kristen.torres@yale.edu
203-785-4799
Georges El Fakhri, PhD, DABR
principal investigator · Yale University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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