Imaging of Traumatic Brain Injury Metabolism Using Hyperpolarized Carbon-13 Pyruvate

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03502967
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Hyperpolarized [1-13C] Pyruvate — DRUG
    Bolus injection of study drug
  • Hyperpolarized [2-13C] Pyruvate — DRUG
    Bolus injection of study drug

Study Details

This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients.

Key Dates

Start date
Jun 1, 2018
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Hyperpolarized [1-13C] Pyruvate
    Injection with hyperpolarized \[1-13C\] Pyruvate during MRI.
  • Experimental: Hyperpolarized [2-13C] Pyruvate
    Injection with hyperpolarized \[2-13C\] Pyruvate during MRI.

Primary Outcome Measure

[1-13C]lactate-to-H13CO3- ratio from [1-13C]pyruvate or [2-13C]lactate-to-[5-13C]glutamate ratio from [2-13C]pyruvate [ Time Frame: One visit of three hours: 2 bolus injections during MRI with 45 minute rest period between the two ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern - Advanced Imaging Research CenterDallasTexas75390-

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UT Southwestern - Advanced Imaging Research Center· Dallas, TX

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