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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05041166

Enrollment

Registered

2021-09-10

Start date

2021-09-01

Completion date

2026-09-01

Last updated

2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

MRI, Hyperpolarized (HP) [13C] pyruvate, 21-309

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.

Interventions

DRUGHyperpolarized [13C] Pyruvate

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

This in-human study of HP \[13C\]pyruvate MRI at MSKCC will be an open-label study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORVesselin Miloushev, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026