Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06103201
Phase
PHASE1
Status
Recruiting
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Conditions

  • Subarachnoid Hemorrhage
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

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 \[Koletzko et al., 1997\].

Study Details

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).

Key Dates

Start date
Oct 26, 2023
Status verified
May 2025
Primary completion
Nov 26, 2026
Completion
Nov 26, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland BaltimoreBaltimoreMaryland21201
Rosy Linda Njonkou Tchoquessi
[email protected]
410-706-0943
Dirk Mayer, Dr. rer. nat. (PRINCIPAL_INVESTIGATOR)

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