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

The University of Texas System (UT)

Status and phase: Invitation-only; Early Phase 1

Conditions: Brain Metabolism

Study type: Observational

Funder types: Other

Identifiers

NCT03849963

STU-2018-0013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 1 patient group

Hyperpolarized [13C]pyruvate

Description:

Hyperpolarized stable isotope injection (\[13C\]pyruvate) during magnetic resonance spectroscopic imaging