Recruiting
Phase 1

Hyperpolarized 13C-pyruvate

Sponsor:

University of Maryland, Baltimore

Code:

NCT06103201

Conditions

Traumatic Brain Injury

Subarachnoid Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized 13C-Pyruvate

Study Details

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).

Conditions

Traumatic Brain Injury

Subarachnoid Hemorrhage

Study ID

NCT06103201

Start date

Oct 26, 2023

Status verified date

May, 2025

Completion date

Nov 26, 2027

Anticipated

Primary completion date

Nov 26, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Metabolic MRI in traumatic brain injury patients

Perform metabolic magnetic resonance imaging on patients who have traumatic brain injury to understand early brain metabolism changes in this population

experimental: Metabolic MRI in subarachnoid hemorrhage patients

Perform metabolic magnetic resonance imaging on patients who have subarachnoid hemorrhage to understand early brain metabolism changes in this population

experimental: Metabolic MRI in healthy volunteers

Perform metabolic magnetic resonance imaging on healthy volunteers to understand early brain metabolism changes in this population

Interventions

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 \[Koletzko et al., 1997\].

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rosy Linda Njonkou Tchoquessi

410-706-0943rnjonkou@som.umaryland.edu

Locations

University of Maryland Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Rosy Linda Njonkou Tchoquessi

410-706-0943rnjonkou@som.umaryland.edu

Principal Investigator:

Dirk Mayer, Dr. rer. nat.

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

May 11, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-05-11.