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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Hyperpolarized 13C-Pyruvate
DrugHyperpolarized 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 \[Koletzko et al., 1997\].
Treatment groups
15 Participants
are divided into 3 treatment groupsGroup A: Metabolic MRI in traumatic brain injury patientsExperimental treatment 1 intervention
Group B: Metabolic MRI in subarachnoid hemorrhage patientsExperimental treatment 1 intervention
Group C: Metabolic MRI in healthy volunteersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 enrollmentSecondary outcomes
1
Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.
Time frame
within two years post enrollmentSponsors and contacts
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Source ClinicalTrials.gov