Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

Brain Metabolism Clinical Trial

— HP Brain  

Official title:

Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03849963
• Other study ID #: STU-2018-0013
• Status: Enrolling by invitation
• Start date: July 30, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 28
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metabolism

Locations

Country	Name	City	State
United States	UT Southwestern - Advanced Imaging Research Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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