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Hyperpolarized Carbon-13 Pyruvate Imaging for Traumatic Brain Injury (HPTBI Trial)

Phase < 1
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
TBI Patients with injury occurred within 30 days
Subjects aged 18 through 60 years
Must not have
Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements
Significant anatomic distortion of the brain identified on CT images, such as large hematomas, herniation, intraventricular hemorrhage, extensive subarachnoid hemorrhage, hydrocephalus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one visit of three hours: 2 bolus injections during mri with 45 minute rest period between the two
Awards & highlights

Summary

This trial is testing a new imaging agent to see if it can detect changes in brain metabolism after traumatic brain injury.

Who is the study for?
This trial is for adults aged 18-60 with a confirmed traumatic brain injury (TBI) based on specific criteria, including Glascow coma scale scores and CT scans. Participants must have had the injury within the last 30 days and be able to consent in English or Spanish. Excluded are those with non-TBI related brain abnormalities, metal in their head that affects MRI, severe mental health issues, drug influence at scanning time, or any MRI contraindications.
What is being tested?
The study tests how well hyperpolarized carbon-13 pyruvate compounds work as imaging agents to show changes in brain metabolism after TBI. It aims to assess mitochondrial dysfunction and cerebral glycolysis using advanced imaging techniques in patients who've recently suffered from TBI.
What are the potential side effects?
Since this trial focuses on imaging rather than medication or invasive treatment, side effects may primarily relate to the MRI process itself such as discomfort from lying still during scanning or reactions if claustrophobic. The contrast agent's side effects are not specified but could include mild allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My traumatic brain injury happened less than 30 days ago.
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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a major neurological condition that would stop me from following the study's requirements.
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My brain scan shows significant changes, like bleeding or swelling.
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I have had a penetrating brain injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one visit of three hours: 2 bolus injections during mri with 45 minute rest period between the two
This trial's timeline: 3 weeks for screening, Varies for treatment, and one visit of three hours: 2 bolus injections during mri with 45 minute rest period between the two for reporting.

Treatment Details

Study Objectives

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Hyperpolarized [2-13C] PyruvateExperimental Treatment1 Intervention
Injection with hyperpolarized \[2-13C\] Pyruvate during MRI.
Group II: Hyperpolarized [1-13C] PyruvateExperimental Treatment1 Intervention
Injection with hyperpolarized \[1-13C\] Pyruvate during MRI.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,056,202 Total Patients Enrolled

Media Library

Hyperpolarized [1-13C] Pyruvate Clinical Trial Eligibility Overview. Trial Name: NCT03502967 — Phase < 1
Traumatic Brain Injury Research Study Groups: Hyperpolarized [1-13C] Pyruvate, Hyperpolarized [2-13C] Pyruvate
Traumatic Brain Injury Clinical Trial 2023: Hyperpolarized [1-13C] Pyruvate Highlights & Side Effects. Trial Name: NCT03502967 — Phase < 1
Hyperpolarized [1-13C] Pyruvate 2023 Treatment Timeline for Medical Study. Trial Name: NCT03502967 — Phase < 1
~6 spots leftby Jun 2025
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