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

Phase 1Enrolling By InvitationNCT05041166

Memorial Sloan Kettering Cancer Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Signal-to-noise ratios

will be used to assess image quality, and to compare the different technical setups. The setup providing the highest SNR will be considered optimal.

Time frame: 1 day