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

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ClinicalTrials.gov Identifier: NCT03849963
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Jae Mo Park, University of Texas Southwestern Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Cancer Drug: Hyperpolarized [13C]Pyruvate Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot Study for translational feasibility and repeatability.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyperpolarized [13C]pyruvate
Hyperpolarized stable isotope injection ([13C]pyruvate) during magnetic resonance spectroscopic imaging
Drug: Hyperpolarized [13C]Pyruvate
Injection of hyperpolarized [13C]pyruvate, a stable isotope, during magnetic resonance spectroscopic imaging.




Primary Outcome Measures :
  1. Development of 13C ratio maps in the brain of healthy participants [ Time Frame: Measurements made during study scan ]
    Product ratios (Bicarbonate/Lactate, Glutamate/Lactate) will be acquired from the hyperpolarized 13C imaging



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 or Spanish 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849963


Locations
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United States, Texas
UT Southwestern - Advanced Imaging Research Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center

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Responsible Party: Jae Mo Park, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03849963     History of Changes
Other Study ID Numbers: STU 2018-0013
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs