Brain MetabolismHP BrainNCT03849963
Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
An observational study of Brain Metabolism, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Investigators propose to develop hyperpolarized [13C]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Metabolism
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2030to 31 Dec 2030
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Volunteers
Who may be able to join
- 18 through 60 years of age.
- Healthy, with no neurological abnormalities.
- Ability to understand and the willingness to sign a written informed consent.
- All races and ethnicities will be included; subjects must be able to read and speak the English language.
Who cannot join
- Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions
- Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements
- Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning.
- Under influence of antiepileptic drugs at the time of MRI/MRSI scanning.
- Any contraindication per MRI Screening Form including
- Implants contraindicated at 3T, pacemakers
Show all 14Show fewer
- Implantable Cardioverter Defibrillator (ICD)
- Claustrophobia
- Medically unstable including
- Heart failure
- Severe left ventricular outflow tract (LVOT) obstruction
- Unstable angina
- Pregnancy
- Lactating
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
UT Southwestern - Advanced Imaging Research Center
Dallas, Texas, 75390
Jeannie D Baxter, RN, 214-645-2726, jeannie.baxter@utsouthwestern.edu
About this study
Investigators propose to develop hyperpolarized [13C]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study.
Read the detailed description
Investigators will perform a pilot study to test the translational feasibility by evaluating sensitivity and repeatability of hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate in healthy human subjects (n =10 each). Each subject will be imaged twice using the same hyperpolarized substrate with an interval (<45min) between the injections to evaluate repeatability. Finally, eight subjects will be imaged with both hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate for comparison.
- Conditions
- Brain Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized [13C]pyruvate | Hyperpolarized stable isotope injection ([13C]pyruvate) during magnetic resonance spectroscopic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of 13C ratio maps in the brain of healthy participants
Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging
Measured: Measurements made during study scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start30 Jul 2030 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetabolismStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Mo Park, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849963
- Sponsor's protocol ID
- STU-2018-0013
- Acronym
- HP Brain
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2019
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
- ClinicalTrials.gov ID
- NCT03849963
- Acronym / sponsor ID
- HP Brain / STU-2018-0013
- Conditions
- Brain Metabolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 30 Jul 2030 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Feb 2019 (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.
Investigators propose to develop hyperpolarized [13C]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study.
Detailed description
Investigators will perform a pilot study to test the translational feasibility by evaluating sensitivity and repeatability of hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate in healthy human subjects (n =10 each). Each subject will be imaged twice using the same hyperpolarized substrate with an interval (<45min) between the injections to evaluate repeatability. Finally, eight subjects will be imaged with both hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate for comparison.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized [13C]pyruvate | – | –Hyperpolarized stable isotope injection ([13C]pyruvate) during magnetic resonance spectroscopic imaging |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Volunteers
Key inclusion criteria (4 listed)
- 18 through 60 years of age.
- Healthy, with no neurological abnormalities.
- Ability to understand and the willingness to sign a written informed consent.
- All races and ethnicities will be included; subjects must be able to read and speak the English language.
Key exclusion criteria (14 listed)
- Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions
- Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements
- Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning.
- Under influence of antiepileptic drugs at the time of MRI/MRSI scanning.
- Any contraindication per MRI Screening Form including
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of 13C ratio maps in the brain of healthy participants
Time frame: Measurements made during study scan
Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C 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 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
UT Southwestern - Advanced Imaging Research Center
Dallas, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metabolism, run by University of Texas Southwestern Medical Center 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 14 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 12 Mar 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of 13C ratio maps in the brain of healthy participants (time frame: Measurements made during study scan). 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 12 Mar 2026.