What this study is
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).
What's being tested
- Hyperpolarized 13C-Pyruvate
Intervention · 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
- Official title
- Utility of Hyperpolarized 13C-Pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis of Early Cerebral Metabolic Crisis After Traumatic Brain Injury
- Sponsor
- University of Maryland, Baltimore
- Conditions
- Traumatic Brain Injury · Subarachnoid Hemorrhage
- Enrolling
- 15 people
- Starts
- 2023-10-26
- Est. completion
- 2027-11-26
- Design
- Open-label, non-randomized, parallel groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers AcceptedYou 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 can't join if
- Inability to undergo MRI scan
- Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency
- Positive pregnancy test
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Maryland Baltimore
Baltimore, Maryland, United States
- Rosy Linda Njonkou Tchoquessi · Contact410-706-0943rnjonkou@som.umaryland.edu
- Dirk Mayer, Dr. rer. nat. · Principal investigator
Recruiting
Study team
Sponsor
University of Maryland, Baltimore
Study ID HP-00104422
Principal investigator
Dirk Mayer, Dr. rer. nat.
University of Maryland, Baltimore
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.