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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Invitation-only
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Hyperpolarized [13C] Pyruvate

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Protocol optimization cohort
Experimental group
Description:
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.
Treatment:
Drug: Hyperpolarized [13C] Pyruvate
Tissue reference cohort
Experimental group
Description:
The optimal setup will then be used for HP MRI of the second cohort.
Treatment:
Drug: Hyperpolarized [13C] Pyruvate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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