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Metabolic MRI with Hyperpolarized Pyruvate for Traumatic Brain Injury

Phase 1

Recruiting

Led By Dirk Mayer, Dr. rer. nat.

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of acute head injury with or suspected non-penetrating acute TBI

Suitable to undergo contrast-enhanced MRI

Must not have

Inability to receive IV MRI contrast agents secondary to severe reaction or renal insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within two years post enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if metabolic MRI scans can better diagnose TBI by comparing HP 13C-pyruvate MRI-derived metrics in TBI patients to those of healthy and SAH patients.

Who is the study for?

This trial is for up to 15 people with a recent head injury suspected of non-penetrating traumatic brain injury (TBI), including those who can safely have an MRI with contrast and are not pregnant. It excludes individuals who cannot undergo MRI scans, have had severe reactions or kidney issues preventing them from receiving IV MRI contrast agents, or are pregnant.

What is being tested?

The study tests the safety and feasibility of using a special type of metabolic MRI scan called hyperpolarized 13C-Pyruvate (HP 13C-pyruvate) to detect changes in brain metabolism after TBI. It will compare results from TBI patients, subarachnoid hemorrhage patients, and healthy volunteers at UMB.

What are the potential side effects?

While specific side effects aren't detailed here, typical risks may include discomfort during the MRI procedure or potential reactions to the IV contrast agent used in the imaging process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a recent head injury without an open wound.

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I can safely have an MRI with contrast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot have IV MRI contrast due to a severe reaction or kidney issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within two years post enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within two years post enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within two years post enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Metabolic MRI in traumatic brain injury patientsExperimental Treatment1 Intervention

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

Group II: Metabolic MRI in subarachnoid hemorrhage patientsExperimental Treatment1 Intervention

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

Group III: Metabolic MRI in healthy volunteersExperimental Treatment1 Intervention

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

0 / 3Eligibility criteria met