Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Metabolic MRI in traumatic brain injury patients |
Perform metabolic magnetic resonance imaging on patients who have traumatic brain injury to understand early brain metabolism changes in this population |
|
Experimental Metabolic MRI in subarachnoid hemorrhage patients |
Perform metabolic magnetic resonance imaging on patients who have subarachnoid hemorrhage to understand early brain metabolism changes in this population |
|
Experimental Metabolic MRI in healthy volunteers |
Perform metabolic magnetic resonance imaging on healthy volunteers to understand early brain metabolism changes in this population |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore