Traumatic Brain InjuryEarly Phase 1HPTBINCT03502967
Imaging of Traumatic Brain Injury Metabolism Using Hyperpolarized Carbon-13 Pyruvate
A Early Phase 1 study testing Hyperpolarized [1-13C] Pyruvate and Hyperpolarized [2-13C] Pyruvate in people with Traumatic Brain Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Hyperpolarized [1-13C] Pyruvate and Hyperpolarized [2-13C] Pyruvate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 30 Dec 2026
- Phase
- Early 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- TBI Patients
- Injury occurred within 30 days
- Documented and verified TBI by Glascow coma scal 10-15 and/or Loss of Consciousness >10 minutes.
- Head Computed Tomography at admission.
- ALL Subjects:
- 18 through 60 years of age.
- Ability to understand the the willingness to sign a writteninformed consent.
- All races and ethnicities will be included; subjects must be able to read and speak either the English or Spanish language.
Who cannot join
- Non-traumatic structural brain abnormality identified on head CT.
- Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions.
- Penetrating TBI.
- Significant anatomic distortion of the brain identified on CT images, such as large hematomas, herniation, intraventricular hemorrhage, extensive subarachnoid hemorrhage, hydrocephalus.
- Significant polytrauma that would interfere with follow-up and outcome assessment.
- Patients on psychiatric hold.
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- Major debilitating mental health disorders including, but not limited to schizophrenia and bipolar disorder that would limit compliance with study requirements.
- 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.
- Any contraindication per MRI Screening Form including
- Implants contraindicated at 3T, pacemakers
- Implantable Cardioverter Defibrillator (ICD)
- Claustrophobia
- Prisoners or patients in custody.
- Medically unstable including
- Heart failure
- Severe left ventricular outflow tract (LVOT) obstruction
- Unstable angina
- Pregnancy
- Lactating
- Subjects who are receiving any other investigational agents.
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
UT Southwestern - Advanced Imaging Research Center
Dallas, Texas, 75390
About this study
This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients.
Read the detailed description
Aim 1:
Investigators will quantify changes in [1-13C]lactate and H13CO3- labeling following a bolus injection of hyperpolarized [1-13C]pyruvate during the time window of secondary injury to assess upregulated glycolysis. Due to heterogeneous presence and severity of damage by TBI, defining the injured brain region can be difficult. Therefore, the metabolite ratio maps ([product]/[pyruvate]) of TBI patients (n = 5) will be compared with those of healthy-controls (n = 3).
Hyperpolarized [2-13C]pyruvate will be examined in a separate group of TBI cohorts (n = 5) and healthy controls (n = 3), and [5-13C]glutamate, [1-13C]acetyl-carnitine, [1-13C]acetoacetate, and [1-13C]citrate from [2-13C]pyruvate will be quantified for assessing the altered mitochondrial metabolism. Imaging procedure with [2-13C]pyruvate is the same as the imaging with hyperpolarized [1-13C]pyruvate.
For both [1-13C]pyruvate and [2-13C]pyruvate studies, each subject will be imaged twice with a 45min interval for confirming the reproducibility of the methods and/or averaging to enhance the signal-to-noise ratios of 13C-metabolite maps.
Aim 2:
After the feasibility study (aim1) is completed, an intra-subject comparison study of [1-13C]pyruvate and [2-13C]pyruvate will be performed. Similar to the aim1, patients with post-TBI neurological disorders having normal or near-normal CT results (n = 6 patients) as well as normal brains of age/gender-matching healthy volunteers (n = 3) will be recruited. Each patient will be imaged twice (one with [1-13C]pyruvate and one with [2-13C]pyruvate with a 45min interval). PDH activity and the TCA cycling will be assessed from measured H13CO3- from hyperpolarized [1-13C]pyruvate and [5-13C]glutamate from [2-13C]pyruvate, respectively. The comparison of [1-13C]pyruvate and [2-13C]pyruvate will identify the detailed information of how pyruvate (and converted acetyl-CoA) is utilized in the mitochondria, and assess the utility and necessity of imaging hyperpolarized [2-13C]pyruvate in TBI, providing critical data for future grant applications and larger clinical trials.
- Conditions
- Traumatic Brain Injury
- Being tested
- Hyperpolarized [1-13C] Pyruvate, Hyperpolarized [2-13C] Pyruvate
- Keywords
- Traumatic Brain Injury, TBI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized [1-13C] PyruvateDrug
Also called HP Pyruvate Injection
Bolus injection of study drug
Hyperpolarized [2-13C] PyruvateDrug
Also called HP Pyruvate Injection
Bolus injection of study drug
| Study group | Role | What they receive |
|---|---|---|
| Hyperpolarized [1-13C] Pyruvate | Experimental | Injection with hyperpolarized [1-13C] Pyruvate during MRI. Receives: Drug: Hyperpolarized [1-13C] Pyruvate |
| Hyperpolarized [2-13C] Pyruvate | Experimental | Injection with hyperpolarized [2-13C] Pyruvate during MRI. Receives: Drug: Hyperpolarized [2-13C] Pyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
[1-13C]lactate-to-H13CO3- ratio from [1-13C]pyruvate or [2-13C]lactate-to-[5-13C]glutamate ratio from [2-13C]pyruvate
Product ratio maps of lactate from pyruvate in the brain of TBI patients as compared to those of healthy controls.
Measured: One visit of three hours: 2 bolus injections during MRI with 45 minute rest period between the two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Jun 2018
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- TBI patients and healthy control subjects
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT03502967
- Sponsor's protocol ID
- STU 072017-009
- Acronym
- HPTBI
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2018
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Traumatic Brain Injury Metabolism Using Hyperpolarized Carbon-13 Pyruvate
- ClinicalTrials.gov ID
- NCT03502967
- Acronym / sponsor ID
- HPTBI / STU 072017-009
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, TBI
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Apr 2018 (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.
This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients.
Detailed description
Aim 1:
Investigators will quantify changes in [1-13C]lactate and H13CO3- labeling following a bolus injection of hyperpolarized [1-13C]pyruvate during the time window of secondary injury to assess upregulated glycolysis. Due to heterogeneous presence and severity of damage by TBI, defining the injured brain region can be difficult. Therefore, the metabolite ratio maps ([product]/[pyruvate]) of TBI patients (n = 5) will be compared with those of healthy-controls (n = 3).
Hyperpolarized [2-13C]pyruvate will be examined in a separate group of TBI cohorts (n = 5) and healthy controls (n = 3), and [5-13C]glutamate, [1-13C]acetyl-carnitine, [1-13C]acetoacetate, and [1-13C]citrate from [2-13C]pyruvate will be quantified for assessing the altered mitochondrial metabolism. Imaging procedure with [2-13C]pyruvate is the same as the imaging with hyperpolarized [1-13C]pyruvate.
For both [1-13C]pyruvate and [2-13C]pyruvate studies, each subject will be imaged twice with a 45min interval for confirming the reproducibility of the methods and/or averaging to enhance the signal-to-noise ratios of 13C-metabolite maps.
Aim 2:
After the feasibility study (aim1) is completed, an intra-subject comparison study of [1-13C]pyruvate and [2-13C]pyruvate will be performed. Similar to the aim1, patients with post-TBI neurological disorders having normal or near-normal CT results (n = 6 patients) as well as normal brains of age/gender-matching healthy volunteers (n = 3) will be recruited. Each patient will be imaged twice (one with [1-13C]pyruvate and one with [2-13C]pyruvate with a 45min interval). PDH activity and the TCA cycling will be assessed from measured H13CO3- from hyperpolarized [1-13C]pyruvate and [5-13C]glutamate from [2-13C]pyruvate, respectively. The comparison of [1-13C]pyruvate and [2-13C]pyruvate will identify the detailed information of how pyruvate (and converted acetyl-CoA) is utilized in the mitochondria, and assess the utility and necessity of imaging hyperpolarized [2-13C]pyruvate in TBI, providing critical data for future grant applications and larger clinical trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- TBI patients and healthy control subjects
| Arm | Type | Receives |
|---|---|---|
| Hyperpolarized [1-13C] Pyruvate | Experimental | Drug: Hyperpolarized [1-13C] PyruvateInjection with hyperpolarized [1-13C] Pyruvate during MRI. |
| Hyperpolarized [2-13C] Pyruvate | Experimental | Drug: Hyperpolarized [2-13C] PyruvateInjection with hyperpolarized [2-13C] Pyruvate during MRI. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- TBI Patients
- Injury occurred within 30 days
- Documented and verified TBI by Glascow coma scal 10-15 and/or Loss of Consciousness >10 minutes.
- Head Computed Tomography at admission.
- 18 through 60 years of age.
Key exclusion criteria (21 listed)
- Non-traumatic structural brain abnormality identified on head CT.
- Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions.
- Penetrating TBI.
- Significant anatomic distortion of the brain identified on CT images, such as large hematomas, herniation, intraventricular hemorrhage, extensive subarachnoid hemorrhage, hydrocephalus.
- Significant polytrauma that would interfere with follow-up and outcome assessment.
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 |
|---|---|---|
| Hyperpolarized [1-13C] PyruvateAlso: HP Pyruvate InjectionBolus injection of study drug | Drug | Hyperpolarized [1-13C] Pyruvate |
| Hyperpolarized [2-13C] PyruvateAlso: HP Pyruvate InjectionBolus injection of study drug | Drug | Hyperpolarized [2-13C] Pyruvate |
Primary outcome
[1-13C]lactate-to-H13CO3- ratio from [1-13C]pyruvate or [2-13C]lactate-to-[5-13C]glutamate ratio from [2-13C]pyruvate
Time frame: One visit of three hours: 2 bolus injections during MRI with 45 minute rest period between the two
Product ratio maps of lactate from pyruvate in the brain of TBI patients as compared to those of healthy controls.
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 3 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyperpolarized [1-13C] Pyruvate and Hyperpolarized [2-13C] Pyruvate in people with Traumatic Brain Injury, 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 8 inclusion and 21 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[1-13C]lactate-to-H13CO3- ratio from [1-13C]pyruvate or [2-13C]lactate-to-[5-13C]glutamate ratio from [2-13C]pyruvate (time frame: One visit of three hours: 2 bolus injections during MRI with 45 minute rest period between the two). 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 3 Sep 2026.