Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain (HP Brain)

Investigators propose to develop hyperpolarized [13C]-labeled pyruvate as potential imaging probes to assess two essential in vivo processes in cerebral metabolism: oxidative metabolism and synthesis of a neurotransmitter in this observational study.

Study Overview

• Status: Enrolling by invitation
• Conditions: Brain Metabolism

Detailed Description

Investigators will perform a pilot study to test the translational feasibility by evaluating sensitivity and repeatability of hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate in healthy human subjects (n =10 each). Each subject will be imaged twice using the same hyperpolarized substrate with an interval (<45min) between the injections to evaluate repeatability. Finally, eight subjects will be imaged with both hyperpolarized [1-13C]pyruvate and [2-13C]pyruvate for comparison.

• Study Type: Observational
• Enrollment (Estimated): 28

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern - Advanced Imaging Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

Description

Inclusion Criteria:

• 18 through 60 years of age.
• Healthy, with no neurological abnormalities.
• Ability to understand and the willingness to sign a written informed consent.
• All races and ethnicities will be included; subjects must be able to read and speak the English language.

Exclusion Criteria:

• Metallic foreign bodies on the scalp or cranium which may interfere with MRI acquisitions
• 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.
• Under influence of antiepileptic drugs at the time of MRI/MRSI scanning.
• Any contraindication per MRI Screening Form including
• Implants contraindicated at 3T, pacemakers
• Implantable Cardioverter Defibrillator (ICD)
• Claustrophobia
• Medically unstable including
• Heart failure
• Severe left ventricular outflow tract (LVOT) obstruction
• Unstable angina
• Pregnancy
• Lactating

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hyperpolarized [13C]pyruvate; Hyperpolarized stable isotope injection ([13C]pyruvate) during magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of 13C ratio maps in the brain of healthy participants	Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging	Measurements made during study scan

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STU-2018-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No