Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Maryland, Baltimore
About this trial
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).
Eligibility criteria
Qualifiers
History of acute head injury with or suspected non-penetrating acute TBI
Suitable to undergo contrast-enhanced MRI
Negative serum pregnancy test
Disqualifiers
Inability to undergo MRI scan
Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency
Positive pregnancy test
Trial design
Treatments tested in this trial
- Hyperpolarized 13C-Pyruvate
Treatment groups
15 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov