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

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

NCT05041166

21-309

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)

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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