NCT03849963

Recruiting

Imaging Oxidative Metabolism and Neurotransmitter Synthesis ...

University of Texas Southwestern Medical Center Source

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Other study identifiers

Sponsor study identifier

STU-2018-0013

Study Type

observational

Estimated enrollment

28

Locations

1 country

Sites

1

Timeline

Study Start

July 30, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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 in this observational study.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 28 participants
Study completion date: December 31, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 14, 2019
Actual (reported)
First Posted
February 21, 2019
Actual (reported)
Study Start
July 30, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: March 12, 2026
Status Verified: March 2026
Last Update Submitted: March 9, 2026

Conditions

Brain Metabolism

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Hyperpolarized [13C]pyruvate

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

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

through 60 years of age.

Sponsors & Collaborators

University of Texas Southwestern Medical Center
Otherlead

Study Sites (1)

UT Southwestern - Advanced Imaging Research Center

Dallas, Texas, 75390, United States

RECRUITING

Jeannie D Baxter, RNCONTACT214-645-2726 jeannie.baxter@utsouthwestern.edu

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 21, 2019

Study Start

July 30, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 31, 2030

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03849963
Data provider: ClinicalTrials.gov
Source updated: 2026-03-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:19 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Hyperpolarized [13C]pyruvate

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations