Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06103201
• Other study ID #: HP-00104422
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2023
• Est. completion date: November 26, 2026

Study information

• Verified date: April 2024
• Source: University of Maryland, Baltimore
• Contact: Rosy Linda Njonkou Tchoquessi
• Phone: 410-706-0943
• Email: rnjonkou[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: November 26, 2026
• Est. primary completion date: November 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Subarachnoid Hemorrhage
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Drug:
• Hyperpolarized 13C-Pyruvate
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].

Locations

Country	Name	City	State
United States	University of Maryland Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within two years post enrollment
Secondary	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