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RecruitingAccepts healthy volunteersPhase 1

Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

University of Maryland, Baltimore · NCT06103201

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
15
US sites recruiting
1
Study start
October 26, 2023
Record last updated
May 11, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Hyperpolarized 13C-Pyruvate

Conditions: Traumatic Brain Injury; Subarachnoid Hemorrhage

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • University of Maryland Baltimore

    Baltimore, MD 21201

    Site contact: Rosy Linda Njonkou Tchoquessi · 410-706-0943 · rnjonkou@som.umaryland.edu

Study contacts (from the official record)

  • Rosy Linda Njonkou Tchoquessi · 410-706-0943 · rnjonkou@som.umaryland.edu
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Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury (NCT06103201) | Bored Studies