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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial will help researchers learn more about how [13C]pyruvate is metabolized in healthy organs and tissues, which will in turn improve MRI scans.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Signal-to-noise ratios

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,550,572 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,572 Total Patients Enrolled
Marius Mayerhoefer, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Hyperpolarized [13C] Pyruvate Clinical Trial Eligibility Overview. Trial Name: NCT05041166 — Phase 1
Healthy Subjects Research Study Groups: Protocol optimization cohort, Tissue reference cohort
Healthy Subjects Clinical Trial 2023: Hyperpolarized [13C] Pyruvate Highlights & Side Effects. Trial Name: NCT05041166 — Phase 1
Hyperpolarized [13C] Pyruvate 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041166 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05041166 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a participant meet to be eligible for the trial?

"To be eligible to participate in this clinical trial, individuals must possess healthy subjectivity and fall within the age bracket of 18-80. 50 participants will ultimately be admitted into the experiment."

Answered by AI

Are individuals aged 30+ being incorporated into this research endeavor?

"Eligibility criteria for this medical trial includes individuals aged 18 or above, but below 80 years of age."

Answered by AI

Is the Hyperpolarized [13C] Pyruvate technique granted authorization by the FDA?

"Due to the introductory nature of this trial, our team at Power has assigned Hyperpolarized [13C] Pyruvate a score of 1 on its risk-to-benefit scale. This is given that there is only nominal data available in terms of safety and efficacy."

Answered by AI

Is there still time for people to join this trial?

"Information accessible on clinicaltrials.gov reveals that enrollment for this particular medical trial is suspended. Initially posted in September of 2021 and last updated on June 7th 2022, the project no longer needs participants; however, 841 other trials remain open to volunteers."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long does the screening process take?
PatientReceived no prior treatments

Why did patients apply to this trial?

I am curious and also would like to be a part of making the MRI process more streamlined.
PatientReceived no prior treatments
I have spinal stenosis L1 region. Your scan might clarify why that condition has worsened as well as be beneficial to MRI procedures.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers
2021. "A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05041166.
~17 spots leftby Sep 2025
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