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

NCT ID: NCT05041166

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-09-30

Brief Summary

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyperpolarized [13C] Pyruvate

Intervention Type: DRUG

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

Tissue reference cohort

The optimal setup will then be used for HP MRI of the second cohort.

Group Type: EXPERIMENTAL

Hyperpolarized [13C] Pyruvate

Intervention Type: DRUG

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

Interventions

Hyperpolarized [13C] Pyruvate

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vesselin Miloushev, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

21-309

Identifier Type: -

Identifier Source: org_study_id