A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyperpolarized [13C] Pyruvate.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs
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.
Interventions
- Drug Hyperpolarized [13C] Pyruvate
Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight
Primary outcome measures
- Signal-to-noise ratios [Time frame: 1 day]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Memorial Sloan Kettering Cancer Center — New York
Identifiers
NCT: NCT05041166 · 21-309