Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

Phase 1

Recruiting

• Conditions: Traumatic Brain Injury; Subarachnoid Hemorrhage
• Interventions: Drug: Hyperpolarized 13C-Pyruvate

• Registration Number: NCT06103201
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-10-21
• Study Start: 2023-10-26
• Study First Posted: 2023-10-26
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-11-26
• Study Completion: 2027-11-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metabolic MRI in traumatic brain injury patients	Hyperpolarized 13C-Pyruvate	Perform metabolic magnetic resonance imaging on patients who have traumatic brain injury to understand early brain metabolism changes in this population
Metabolic MRI in subarachnoid hemorrhage patients	Hyperpolarized 13C-Pyruvate	Perform metabolic magnetic resonance imaging on patients who have subarachnoid hemorrhage to understand early brain metabolism changes in this population
Metabolic MRI in healthy volunteers	Hyperpolarized 13C-Pyruvate	Perform metabolic magnetic resonance imaging on healthy volunteers to understand early brain metabolism changes in this population

Primary Outcome Measures

Name	Time	Method
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)	within two years post enrollment	To assess the differences between the three patient groups

Secondary Outcome Measures

Name	Time	Method
Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.	within two years post enrollment

Trial Locations

Locations (1)

University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States