Traumatic Brain InjuryPhase 1NCT06103201
Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
A Phase 1 study testing Hyperpolarized 13C-Pyruvate in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- What is being tested?
- Hyperpolarized 13C-Pyruvate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2023to 26 Nov 2027
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of acute head injury with or suspected non-penetrating acute TBI
- Suitable to undergo contrast-enhanced MRI
- Negative serum pregnancy test
Who cannot join
- Inability to undergo MRI scan
- Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency
- Positive pregnancy test
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
University of Maryland Baltimore
Baltimore, Maryland, 21201
Rosy Linda Njonkou Tchoquessi, 410-706-0943, rnjonkou@som.umaryland.edu
Dirk Mayer, Dr. rer. nat.
About this study
Official title: Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI.
The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study.
Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Being tested
- Hyperpolarized 13C-Pyruvate
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 13C-PyruvateDrug
Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") [13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, traumatic brain injury.
Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, which refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997].
| Study group | Role | What they receive |
|---|---|---|
| Metabolic MRI in traumatic brain injury patients | Experimental | Perform metabolic magnetic resonance imaging on patients who have traumatic brain injury to understand early brain metabolism changes in this population Receives: Drug: Hyperpolarized 13C-Pyruvate |
| Metabolic MRI in subarachnoid hemorrhage patients | Experimental | Perform metabolic magnetic resonance imaging on patients who have subarachnoid hemorrhage to understand early brain metabolism changes in this population Receives: Drug: Hyperpolarized 13C-Pyruvate |
| Metabolic MRI in healthy volunteers | Experimental | Perform metabolic magnetic resonance imaging on healthy volunteers to understand early brain metabolism changes in this population Receives: Drug: Hyperpolarized 13C-Pyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio)
To assess the differences between the three patient groups
Measured: within two years post enrollment
Secondary outcomes (1)
Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.
Measured: within two years post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start26 Oct 2023
- Primary completion26 Nov 2026 (estimated)
- Study completion26 Nov 2027 (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 Maryland, BaltimoreThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiachen Zhuo, University of Maryland, Baltimore
- Investigators
- Dirk Mayer, Dr. rer. nat., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103201
- Sponsor's protocol ID
- HP-00104422
- Status last verified
- May 2025
- First submitted
- 28 Sep 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06103201
- Acronym / sponsor ID
- HP-00104422
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 26 Nov 2027 (estimated)
- First posted
- 26 Oct 2023 (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.
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI.
The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study.
Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metabolic MRI in traumatic brain injury patients | Experimental | Drug: Hyperpolarized 13C-PyruvatePerform metabolic magnetic resonance imaging on patients who have traumatic brain injury to understand early brain metabolism changes in this population |
| Metabolic MRI in subarachnoid hemorrhage patients | Experimental | Drug: Hyperpolarized 13C-PyruvatePerform metabolic magnetic resonance imaging on patients who have subarachnoid hemorrhage to understand early brain metabolism changes in this population |
| Metabolic MRI in healthy volunteers | Experimental | Drug: Hyperpolarized 13C-PyruvatePerform metabolic magnetic resonance imaging on healthy volunteers to understand early brain metabolism changes in this population |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of acute head injury with or suspected non-penetrating acute TBI
- Suitable to undergo contrast-enhanced MRI
- Negative serum pregnancy test
Key exclusion criteria (3 listed)
- Inability to undergo MRI scan
- Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency
- Positive pregnancy test
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 13C-PyruvateHyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") [13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, traumatic brain injury. Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, which refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997]. | Drug | Metabolic MRI in healthy volunteers, Metabolic MRI in subarachnoid hemorrhage patients, Metabolic MRI in traumatic brain injury patients |
Primary outcome
Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio)
Time frame: within two years post enrollment
To assess the differences between the three patient groups
1 secondary outcome
Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.
Time frame: within two years post enrollment
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 11 May 2025.
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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.
Dirk Mayer, Dr. rer. nat. principal investigator
University of Maryland, Baltimore
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 Hyperpolarized 13C-Pyruvate in people with Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Maryland, Baltimore 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 3 inclusion and 3 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 11 May 2025. 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 Rosy Linda Njonkou Tchoquessi (410-706-0943, rnjonkou@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio) (time frame: within two years post enrollment). 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 11 May 2025.