Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 1

Conditions: Subarachnoid Hemorrhage; Traumatic Brain Injury

Treatments: Drug: Hyperpolarized 13C-Pyruvate

Study type: Interventional

Funder types: Other

Identifiers

NCT06103201

HP-00104422

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 3 patient groups

Metabolic MRI in traumatic brain injury patients

Experimental group

Description:

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

Treatment:

Drug: Hyperpolarized 13C-Pyruvate

Metabolic MRI in subarachnoid hemorrhage patients

Experimental group

Description:

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

Treatment:

Drug: Hyperpolarized 13C-Pyruvate

Metabolic MRI in healthy volunteers

Experimental group

Description:

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

Treatment:

Drug: Hyperpolarized 13C-Pyruvate