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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within two years post enrollment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Secondary outcome measures

Correlation of the conversion of pyruvate to lactate and pyruvate to bicarbonate measures with results from clinical and neuropsychological evaluation.

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 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,641 Total Patients Enrolled

Dirk Mayer, Dr. rer. nat.Principal InvestigatorUniversity of Maryland, Baltimore

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently recruited for this experiment?

"Indeed, the clinicaltrials.gov website shows that this investigation is currently recruiting participants. This trial was initially publicized on October 26th 2023 and underwent its most recent update on November 2nd 2023. 15 people are required for this study to take place at one research site."

Answered by AI

Is Metabolic MRI a risk-free procedure for those without any health issues?

"As a Phase 1 trial, there is limited evidence supporting Metabolic MRI's safety and efficacy in healthy volunteers - our team at Power has thus assigned it an overall score of 1."

Answered by AI

What are the eligibility criteria for participating in this clinical trial?

"The trial is seeking 15 individuals aged 18 to 80 who have experienced a traumatic brain injury. In order for enrollment, applicants must be suitable for contrast-enhanced MRI scans; possess a documented history of an acute head trauma with or without the suspicion of non-penetrating TBI; and present negative pregnancy test results."

Answered by AI

Is enrollment for this research experiment still open?

"Clinicaltrials.gov confirms that this research is currently looking for participants. The trial was initially published on October 26th 2023 and further updated November 2nd of the same year."

Answered by AI