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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05041166
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 1, 2021
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Protocol optimization cohort
    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.
  • Experimental: Tissue reference cohort
    The optimal setup will then be used for HP MRI of the second cohort.

Primary Outcome Measure

Signal-to-noise ratios [ Time Frame: 1 day ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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