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RECRUITINGPhase 1INTERVENTIONAL

Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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).

Who May Be Eligible (Plain English)

Who May Qualify: - History of acute head injury with or suspected non-penetrating acute TBI - Suitable to undergo contrast-enhanced MRI - Negative serum pregnancy test Who Should NOT Join This Trial: - Inability to undergo MRI scan - Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency - Positive pregnancy test Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Hyperpolarized 13C-Pyruvate

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 \[Koletzko et al., 1997\].

Locations (1)

University of Maryland Baltimore
Baltimore, Maryland, United States