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

Study Overview
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Brief Summary
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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.

Official Title
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Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Hyperpolarized [13C] Pyruvate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This in-human study of HP [13C]pyruvate MRI at MSKCC will be an open-label study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol optimization cohort<br>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. | Drug: Hyperpolarized [13C] Pyruvate<br>* Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight<br>|
| Experimental: Tissue reference cohort<br>The optimal setup will then be used for HP MRI of the second cohort. | Drug: Hyperpolarized [13C] Pyruvate<br>* Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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21-309, MRI, Hyperpolarized (HP) [13C] pyruvate