Membrane Potential Mapping with18F-TPP

NCT07506616 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20000399397P41EB022544-08
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Membrane Potential Mapping

Outcome Measures

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.

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

Study Arms (1)

18F-TPP

EXPERIMENTAL

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

18F-TPP DRUG

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

18F-TPP

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Yale University PET Center

New Haven, Connecticut, 06510, United States

Location

Study Officials

• Georges El Fakhri, PhD, DABR

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannan Henry

CONTACT

(203) 737-5278; shannan.henry@yale.edu

Kristen Torres, BS

CONTACT

203-785-4799; kristen.torres@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology and Biomedical Imaging, Therapeutic Radiology and of Biomedical Informatics

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2033
• Study Completion (Estimated): August 1, 2033
• Last Updated: May 15, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)