What side effects are associated with this type of intervention?

The most common side effects of gadolinium-based contrast agents, which are used in MRI scans, include mild reactions such as headache, nausea, and dizziness. More severe but rare side effects can include allergic reactions, nephrogenic systemic fibrosis in patients with severe renal dysfunction, and accumulation of gadolinium in the brain. These side effects are generally well-tolerated in healthy individuals.

What prior FDA approvals exist?

The FDA has approved several imaging agents for MRI scans, though specific approvals for [13C]pyruvate are not detailed in the provided context. Imaging agents like gadolinium-based contrast agents are commonly used to enhance MRI images by altering the magnetic properties of nearby water molecules, improving the visibility of internal structures. These agents are typically used in both healthy subjects and patients to diagnose and monitor various conditions. The study of [13C]pyruvate aims to explore its distribution and metabolism in healthy organs and tissues, potentially offering a new tool for enhanced MRI imaging.

What other types of research exist?

Promising novel alternatives to [13C]pyruvate for MRI scans in healthy subjects include gadolinium-based contrast agents, which are widely used and have a well-documented safety profile. Additionally, hyperpolarized agents like [13C]urea and [13C]bicarbonate are being explored for their potential to provide detailed metabolic information similar to [13C]pyruvate.

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Hyperpolarized [13C] Pyruvate Imaging for Healthy Subjects

Phase 1

Waitlist Available

Led By Marius Mayerhoefer, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying how a special substance can make MRI scans clearer. The researchers are focusing on healthy volunteers to see how this substance spreads and changes into energy in their organs and tissues. This substance has shown promise in cancer diagnosis and treatment response assessment.

Who is the study for?

This trial is for healthy individuals aged 18-80. Women of childbearing age must have a negative pregnancy test before joining. The study excludes those with acute major illnesses, an inability to tolerate MRI scans (like claustrophobia), MR unsafe devices in their body, or history of metabolic and renal disorders.

What is being tested?

[13C]Pyruvate is being tested as an imaging agent for MRI scans in this study. Researchers want to understand how it's distributed in the body and metabolized by healthy organs and tissues during the scanning process.

What are the potential side effects?

Since [13C]Pyruvate is used as an imaging agent rather than a drug, side effects may be minimal but could include reactions related to the MRI procedure itself such as discomfort from lying still or temporary feelings of warmth.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any severe illnesses like heart problems or widespread cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Signal-to-noise ratios

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Tissue reference cohortExperimental Treatment1 Intervention

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

Group II: Protocol optimization cohortExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The study focuses on [13C]pyruvate, a compound used as an imaging agent in MRI scans. [13C]pyruvate enhances MRI imaging by providing a clearer picture of metabolic processes in organs and tissues. This is particularly important for healthy subjects as it allows researchers to understand the normal distribution and metabolism of the agent in the body, which can serve as a baseline for comparison in disease states. By studying [13C]pyruvate in healthy individuals, researchers can optimize its use in clinical settings, ensuring accurate and reliable imaging for diagnostic purposes.

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