Brain Metabolism Observed at 7 Tesla

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05085704
Collaborator
(none)
20
49.6

Study Details

Study Description

Brief Summary

The goal is to develop methodology to monitor flux in the citric acid cycle in brain via 13C nuclear magnetic resonance (NMR) spectroscopy at 7 Tesla.

Detailed Description

The goal is to establish a protocol to 13C-label (from 13C-glucose) several physiological molecules: glucose, lactate, pyruvate and derived compounds. All of these molecules can undergo oxidation in the citric acid cycle. The intent is to study the 13C labeling pattern of these molecules in control and G1D subjects to determine if downstream products (such as 13C bicarbonate or 13C glutamate) due to oxidation in the mitochondria can be detected in brain or in blood by NMR analysis. While inside the instrument, the subjects may also undergo a 7T MR exam to correlate spectroscopy with brain structure.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Brain Metabolism Observed at 7 Tesla in Health and Metabolic Disease.
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Sep 20, 2023
Anticipated Study Completion Date :
Sep 20, 2026

Arms and Interventions

Arm Intervention/Treatment
Adolescents and adults with Glut1 deficiency

Adolescents and adults with previously documented diagnosis of Glut1 Deficiency with diagnosis genetically confirmed or confirmed by PET scan of the brain. Ages 16 to 65 Persons with dental fillings, dental crowns, and short (max.4 cm) dental retainer wires can be included.

Device: Magnetic resonance imaging
Medical imaging technique used in radiology to form pictures of the anatomy.
Other Names:
  • MRI
  • Normal healthy adolescents and adults

    Adolescents or adults in good general health. Ages 16 to 65. Persons with dental fillings, dental crowns, and short (max. 4 cm) dental retainer wires can be included.

    Device: Magnetic resonance imaging
    Medical imaging technique used in radiology to form pictures of the anatomy.
    Other Names:
  • MRI
  • Outcome Measures

    Primary Outcome Measures

    1. Select metabolite abundance measured at 7Tfield strength [Day 1, immediately after 13 C labeled isotope infusion]

      Relative spectral amplitude at equilibrium time point (equilibrium will be defined from the spectra) of the lactate, glucose and bicarbonate spectral peaks arising from infused 13C glucose as measured by magnetic resonance spectroscopy (non contrast brain MRS 7T)

    2. Select metabolite abundance measured at 3T field strength [Day 1, immediately after 13 C labeled isotope infusion]

      Relative spectral amplitude at equilibrium time point (equilibrium will be defined from the spectra) of the lactate, glucose and bicarbonate spectral peaks arising from infused 13C glucose as measured by magnetic resonance spectroscopy (non contrast brain MRS 3T)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Adolescents and adults with previously documented diagnosis of Glut1 Deficiency with diagnosis genetically confirmed or confirmed by PET scan of the brain.

    2. Ages 16 to 65

    3. Persons with dental fillings, dental crowns, and short (max.4 cm) dental retainer wires can be included.

    Exclusion Criteria:
    1. People or patients with uncontrolled seizure disorder, defined as grand mal (not absence) seizure in the preceding 3 months.

    2. Pregnant females will be excluded. A serum or urine pregnancy test will be administered to all females of child bearing potential within 24 hours of administration of the tracer and MRI scan. The pregnancy test will be communicated in person by the study PI. Positive results in subjects 17 years old or younger will be disclosed to parent/guardian only.

    3. Subjects with typical implanted orthopedic metal in bone may be considered for inclusion in a 7T scan providing the implant is not within the volume of the radio frequency coil. The PI and the AIRC Medical Director will discuss each case and determine eligibility.

    4. Persons with ICD, pacemakers, neurostimulators and other such devices will be excluded.

    5. Persons with claustrophobia are excluded.

    6. Persons with questionable ferrous implants, bullets, BB's, and shrapnel will be excluded.

    7. Subjects who are not fluent in English will be excluded because immediate cooperation and the ability to respond to instructions from the investigators are necessary.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Juan Pascual, Professor of Medicine, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT05085704
    Other Study ID Numbers:
    • STU-2021-0560
    First Posted:
    Oct 20, 2021
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022