Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

Phase 1RecruitingNCT06103201

University of Maryland, Baltimore15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury Subarachnoid Hemorrhage

Interventions

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 \[Koletzko et al., 1997\].

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Measures of conversion of pyruvate to lactate (apparent conversion rate constant kPL, lactate-to-pyruvate ratio) and pyruvate to bicarbonate (apparent conversion rate constant kPB, bicarbonate-to-pyruvate ratio)

To assess the differences between the three patient groups

Time frame: within two years post enrollment

Secondary Outcomes

Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.