NCT03849963

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Jul 2030

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
11.4 years until next milestone

Study Start

First participant enrolled

July 30, 2030

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

February 14, 2019

Last Update Submit

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.
  • 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.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern - Advanced Imaging Research Center

Dallas, Texas, 75390, United States

RECRUITING

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 (Estimated)

July 30, 2030

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)