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NCT Number: NCT06103201

Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Dirk Mayer, Dr. rer. nat.

PRINCIPAL_INVESTIGATOR

Rosy Linda Njonkou Tchoquessi

CONTACT

[email protected]

410-706-0943

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperpolarized 13C-Pyruvate

Drug

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].

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)

    Time frame: within two years post enrollment

    To assess the differences between the three patient groups

Secondary 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 enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Rosy Linda Njonkou Tchoquessi

CONTACT

[email protected]

410-706-0943

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 26, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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