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Enrolling by Invitation

NCT Number: NCT05041166

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperpolarized [13C] Pyruvate

Drug

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

Primary outcomes

  1. Signal-to-noise ratios

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Sunnybrook Health Sciences Centre

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2021
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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