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

Phase 1

• Conditions: Healthy Volunteers
• Interventions: Drug: Hyperpolarized [13C] Pyruvate

• Registration Number: NCT05041166
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Fifty healthy volunteers will be included.

• Age between 18-80
• Negative serum or urine pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards & Guidelines), from assays obtained <2 weeks prior to study enrollment. Urine pregnancy tests are only valid for the day of test.

Exclusion Criteria

• Breast-feeding
• History of metabolic (e.g. diabetes) and renal functional disorders.
• Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)
• Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.).
• Standard MRI safety screening will be applied (MRI screening questionnaire); volunteers with MR unsafe devices, or conditional devices where research mode is not allowed, will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol optimization cohort	Hyperpolarized [13C] Pyruvate	Following the \[13C\]pyruvate injection, dynamic imaging and 3D volumetric imaging of volunteers in the first cohort (HP MRI protocol optimization, Aim 1) will be performed on the 3-T MRI scanner, using different \[13C\] RF excitation/detection coils.
Tissue reference cohort	Hyperpolarized [13C] Pyruvate	The optimal setup will then be used for HP MRI of the second cohort.

Primary Outcome Measures

Name	Time	Method
Signal-to-noise ratios	1 day	will be used to assess image quality, and to compare the different technical setups. The setup providing the highest SNR will be considered optimal.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States