Membrane Potential MappingPhase 1NCT07506616
Membrane Potential Mapping with18F-TPP
A Phase 1 study testing 18F-TPP in people with Membrane Potential Mapping, run by Yale University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Membrane Potential Mapping
- What is being tested?
- 18F-TPP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University PET Center
New Haven, Connecticut, 06510
About this study
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:
- 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.
- Conditions
- Membrane Potential Mapping
- Being tested
- 18F-TPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-TPPDrug
radiotracer specific for imaging mitochondrial membrane potential (ΔΨm) administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 18F-TPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracers volume of distribution (VT)
Maps of the 18F-TPP tracer volume of distribution (VT) and ΔΨT based on quantitative analysis of PET imaging.
Measured: Visit 2 (up to 90 days post screening visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2033 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Membrane Potential MappingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Georges El Fakhri, Yale University
- Investigators
- Georges El Fakhri, PhD, DABR, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506616
- Sponsor's protocol ID
- 2000039939
- Other IDs
- 7P41EB022544-08
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Membrane Potential Mapping with18F-TPP
- ClinicalTrials.gov ID
- NCT07506616
- Acronym / sponsor ID
- 2000039939
- Conditions
- Membrane Potential Mapping
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2033 (estimated)
- Study completion
- Aug 2033 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-TPP | Experimental | Drug: 18F-TPPPET 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. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-TPPradiotracer specific for imaging mitochondrial membrane potential (ΔΨm) administered intravenously | Drug | 18F-TPP |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Membrane Potential Mapping
Active, not recruitingObservational study
In Vivo Quantitative Mapping of Mitochondrial Cardiac Membrane Potential in Heart Failure
Mitochondrial Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georges El Fakhri, PhD, DABR principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-TPP in people with Membrane Potential Mapping, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannan Henry ((203) 737-5278, shannan.henry@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tracers volume of distribution (VT) (time frame: Visit 2 (up to 90 days post screening visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.