NCT05041166

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

Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Hyperpolarized [13C] Pyruvate	Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight

Timeline

• Start date: 2021-09-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-09-10
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study