Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

NCT06103201 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HP-00104422
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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)

  To assess the differences between the three patient groups

  within two years post enrollment

Secondary Outcomes (1)

• 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

Study Arms (3)

Metabolic MRI in traumatic brain injury patients

EXPERIMENTAL

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

Drug: Hyperpolarized 13C-Pyruvate

Metabolic MRI in subarachnoid hemorrhage patients

EXPERIMENTAL

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

Drug: Hyperpolarized 13C-Pyruvate

Metabolic MRI in healthy volunteers

EXPERIMENTAL

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

Drug: Hyperpolarized 13C-Pyruvate

Interventions

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 \[Koletzko et al., 1997\].

Metabolic MRI in healthy volunteers; Metabolic MRI in subarachnoid hemorrhage patients; Metabolic MRI in traumatic brain injury patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of acute head injury with or suspected non-penetrating acute TBI
• Suitable to undergo contrast-enhanced MRI
• Negative serum pregnancy test

You may not qualify if:

• Inability to undergo MRI scan
• Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency
• Positive pregnancy test

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Dirk Mayer, Dr. rer. nat.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosy Linda Njonkou Tchoquessi

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 26, 2023
• Study Start: October 26, 2023
• Primary Completion (Estimated): November 26, 2026
• Study Completion (Estimated): November 26, 2027
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (1)