Actively Recruiting
Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury
Led by University of Maryland, Baltimore · Updated on 2025-05-11
15
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of hyperpolarized metabolic magnetic resonance imaging (MRI) to study early brain metabolism changes in people who have had a head injury or suspected non-penetrating traumatic brain injury (TBI). This study aims to compare MRI-derived metabolic measures in TBI patients with those in healthy volunteers and patients with subarachnoid hemorrhage (SAH) to see if this imaging method can improve diagnosis of TBI. The study is in a Phase 1 stage and uses hyperpolarized [1-13C] pyruvate, allowed by the FDA for this purpose. Participants will undergo metabolic MRI scans involving an injection of hyperpolarized 13C-pyruvate, which is studied as a diagnostic agent to visualize metabolism in the brain. The study includes three groups: patients with TBI, patients with SAH, and healthy volunteers. Each participant will have the metabolic MRI performed to assess brain metabolism in their respective groups. During the study, researchers will measure how pyruvate converts to lactate and bicarbonate in the brain within two years after enrollment. They will also correlate these metabolic measures with clinical and neuropsychological evaluations. Up to 15 participants are expected, including 5 with TBI, 5 with SAH, and 5 healthy volunteers. The study includes safety monitoring and follow-up assessments to better understand brain metabolism changes after injury.
CONDITIONS
Brief Title
Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of acute head injury with or suspected non-penetrating acute TBI
- Suitable to undergo contrast-enhanced MRI
- Negative serum pregnancy test
You will not qualify if you...
- Inability to undergo MRI scan
- Inability to receive IV MRI contrast agents due to severe reaction or kidney problems
- Positive pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years post enrollment
Participants undergo hyperpolarized 13C-pyruvate metabolic magnetic resonance imaging to assess early cerebral metabolic changes after traumatic brain injury or other conditions.
1 baseline imaging visit with possible additional follow-up assessments
Trial Site Locations
Total: 1 location
1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
R
Rosy Linda Njonkou Tchoquessi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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