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A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers

NCT05041166 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-20

No results posted yet for this study

Summary

The purpose of the study is to learn about the use of \[13C\]pyruvate as an imaging agent for MRI scans. In past studies, researchers have seen that \[13C\]pyruvate can improve imaging with MRI scans. However, they would like to know more about how the imaging agent is distributed in healthy organs and tissues. This study will provide additional information about the use of \[13C\]pyruvate as an imaging agent for MRI scans, and it will show us how the substance is metabolized (changed into energy) in the organs and tissues of healthy volunteers. For (n=5) volunteers undergoing brain imaging we will compare the standard injection at 5mL/second with a slower infusion (0.1-1mL/second) to achieve a 60 second infusion time, to approach quasi steady-state metabolism and improve SNR.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Hyperpolarized [13C] Pyruvate

Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight

Sponsors & Collaborators

Principal Investigators

  • Vesselin Miloushev, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05041166 on ClinicalTrials.gov