Traumatic Brain InjuryDiagnostics and screeningHealthy volunteersBrain and nervesDrugEarly Phase 1
What this study is
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.
What's being tested
- Hyperpolarized [1-13C] Pyruvate
Intervention · DRUG
- Hyperpolarized [2-13C] Pyruvate
Intervention · DRUG
Both interventions
Bolus injection of study drug
Study details
- Sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Traumatic Brain Injury
- Enrolling
- 60 people
- Starts
- 2018-06-01
- Est. completion
- 2026-12-30
- Design
- Open-label, non-randomized, parallel groups, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 18 through 60 years of age.
- Ability to understand the the willingness to sign a writteninformed consent.
- All races and ethnicities will be included; subjects must be able to read and speak either the English or Spanish language.
- TBI Patients
- Injury occurred within 30 days
- Documented and verified TBI by Glascow coma scal 10-15 and/or Loss of Consciousness >10 minutes.
- Head Computed Tomography at admission.
You can't join if
- Non-traumatic structural brain abnormality identified on head CT.
- Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions.
- Penetrating TBI.
- Significant anatomic distortion of the brain identified on CT images, such as large hematomas, herniation, intraventricular hemorrhage, extensive subarachnoid hemorrhage, hydrocephalus.
- Significant polytrauma that would interfere with follow-up and outcome assessment.
- Patients on psychiatric hold.
- Major debilitating mental health disorders including, but not limited to schizophrenia and bipolar disorder that would limit compliance with study requirements.
- Major debilitating neurological disease including, but not limited to, stroke, CVA, dementia and tumor that would limit compliance with study requirements.
- Under influence of illicit drugs which are known to alter brain physiology/metabolism including, but not limited to cocaine, lysergic acid diethylamide (LSD), and marijuana at the time of MRI/MRSI scanning.
- Any contraindication per MRI Screening Form including; Implants contraindicated at 3T, pacemakers; Implantable Cardioverter Defibrillator (ICD); Claustrophobia; Prisoners or patients in custody.; Medically unstable including; Heart failure; Severe left ventricular outflow tract (LVOT) obstruction; Unstable angina; Pregnancy; Lactating; Subjects who are receiving any other investigational agents.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUT Southwestern - Advanced Imaging Research Center
Dallas, Texas, United States
Study team
Sponsor
University of Texas Southwestern Medical Center
Study ID STU 072017-009
Have questions? The record lists no central contact. Use Consider me and the site team can reach you, or find them through ClinicalTrials.gov ↗.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.