Hyperpolarized 13C-pyruvate Metabolic MRI With 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 patient
| Condition(s) | Traumatic Brain Injury, Subarachnoid Hemorrhage |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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). 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). |
| Who can participate | Inclusion Criteria: * History of acute head injury with or suspected non-penetrating acute TBI * Suitable to undergo contrast-enhanced MRI * Negative serum pregnancy test Exclusion Criteria: * Inability to undergo MRI scan * Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency * Positive pregnancy test |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Maryland, Baltimore |
| Locations | Baltimore, Maryland, United States |
| Start date | 2023-10-26 |
| NCT ID | NCT06103201 |
| Official listing | https://clinicaltrials.gov/study/NCT06103201 |