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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
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

HPTBI Trial 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.Check my eligibility
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.See study design
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.

HPTBI Trial 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.

HPTBI Trial 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

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

HPTBI 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
1,039 Previous Clinical Trials
1,048,039 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

Frequently Asked Questions

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

Are applicants aged 70 or younger qualified for this research trial?

"The eligibility requirements for enrolment in this clinical trial necessitates that applicants are aged between 18 and 60. Separately, there exist 157 trials for minors and 706 studies dedicated to those over the retirement age of 65."

Answered by AI

Are there still opportunities for volunteer participants?

"According to the details recorded on clinicaltrials.gov, this investigation has ended its recruitment phase which began June 1st 2018 and concluded September 28th 2022. Fortunately, there are 906 other trials actively seeking participants at this time."

Answered by AI

Is there a possibility to participate in this research initiative?

"This study is seeking a total of 60 volunteers aged between 18 and 60 who have suffered from brain trauma. To be considered, potential participants must meet these requirements."

Answered by AI
~11 spots leftby Jun 2025