Hyperpolarized [13C] Pyruvate Imaging for Healthy Subjects

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Diabetes, Renal disorders, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Hyperpolarized [13C] Pyruvate Imaging for Healthy Subjects?

Research shows that hyperpolarized [13C] pyruvate imaging can provide detailed metabolic information in real-time, which is useful for detecting early disease changes and monitoring treatment responses. This technique has been successfully used in studies to image metabolic processes in tumors and the heart, suggesting its potential effectiveness in providing valuable insights into cellular metabolism. ^{1 2 3 4 5}

Is hyperpolarized [13C] pyruvate imaging safe for humans?

Studies have shown that hyperpolarized [13C] pyruvate imaging has been safely used in healthy human volunteers to study brain metabolism, with no reported adverse effects. This technique allows researchers to observe metabolic processes in the brain without using harmful radiation. ^{1 4 6 7 8}

How does hyperpolarized [13C] pyruvate imaging differ from other treatments?

Hyperpolarized [13C] pyruvate imaging is unique because it uses a special form of carbon (13C) to create detailed images of how the body processes energy, particularly in the brain. This method allows for real-time tracking of metabolic changes, which is different from traditional imaging techniques that do not provide dynamic metabolic information. ^{2 4 9 10 11}

Research Team

Vesselin Miloushev, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Fifty healthy volunteers will be included

Exclusion Criteria

Breast-feeding

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

Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive [13C]pyruvate injections followed by dynamic and 3D volumetric imaging using MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Hyperpolarized [13C] Pyruvate

Trial Overview [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.

Participant Groups

Group I: Tissue reference cohort Experimental Treatment 1 Intervention

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

Group II: Protocol optimization cohort Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Findings from Research

Hyperpolarized 13C magnetic resonance spectroscopic (MRS) imaging, particularly using [1-13C]pyruvate, allows for non-invasive real-time detection of metabolic processes, such as lactate and bicarbonate production, without ionizing radiation.

This technique has shown potential in clinical studies for assessing metabolic changes in conditions like cancer and heart ischemia, indicating its future role in advanced metabolic imaging despite needing further technical improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized MRI - An Update and Future Perspectives. Jørgensen, SH., Bøgh, N., Hansen, E., et al.[2022]

The study successfully developed methods to prepare hyperpolarized [2-13C]pyruvate for the first human NMR studies, demonstrating its feasibility for investigating brain energy metabolism in four healthy volunteers.

Results showed that the conversion of hyperpolarized [2-13C]pyruvate to [2-13C]lactate and [5-13C]glutamate can be measured, with conversion rates comparable to previous studies using [1-13C]pyruvate, indicating the potential for this technique in metabolic research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First hyperpolarized [2-13C]pyruvate MR studies of human brain metabolism. Chung, BT., Chen, HY., Gordon, J., et al.[2022]

A stable hyperpolarized solution of [1-(13)C]-ethyl pyruvate was successfully developed, allowing for its use in metabolic imaging studies.

In a study involving anesthetized rats, hyperpolarized [1-(13)C]-ethyl pyruvate was compared to [1-(13)C]-pyruvate, demonstrating its potential for effective uptake and metabolic imaging in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic imaging in the anesthetized rat brain using hyperpolarized [1-13C] pyruvate and [1-13C] ethyl pyruvate. Hurd, RE., Yen, YF., Mayer, D., et al.[2021]

Using multi-resolution hyperpolarized 13C pyruvate MRI in 6 subjects improved the measurement of kinetic conversion rates in the human brain, particularly by enhancing spatial resolution and reducing partial volume effects.

Higher resolution images (7.5 × 7.5 mm2) led to more accurate calculations of pyruvate-to-lactate conversion rates, especially in areas near blood vessels, indicating that finer resolution can significantly enhance metabolic data quality in brain imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetic analysis of multi-resolution hyperpolarized 13 C human brain MRI to study cerebral metabolism. Hu, JY., Kim, Y., Autry, AW., et al.[2023]

This study demonstrates the successful use of hyperpolarized 13C spectroscopy to detect metabolic products in the rat brain, specifically identifying [1-(13)C]lactate and [13C]bicarbonate after injecting [1-(13)C]pyruvate.

The research highlights the potential of using hyperpolarized [2-(13)C]pyruvate to detect [2-(13)C]lactate, although it did not reveal other metabolites, indicating that different pyruvate isotopes can yield varying insights into metabolic processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo 13C spectroscopy in the rat brain using hyperpolarized [1-(13)C]pyruvate and [2-(13)C]pyruvate. Marjańska, M., Iltis, I., Shestov, AA., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hyperpolarized MRI - An Update and Future Perspectives. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Robust hyperpolarized (13)C metabolic imaging with selective non-excitation of pyruvate (SNEP). [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Metabolite-Specific Echo Planar Imaging for Preclinical Studies with Hyperpolarized 13C-Pyruvate MRI. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

First hyperpolarized [2-13C]pyruvate MR studies of human brain metabolism. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cardiovascular applications of hyperpolarized contrast media and metabolic tracers. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Quantifying normal human brain metabolism using hyperpolarized [1-13C]pyruvate and magnetic resonance imaging. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Initial Experience on Hyperpolarized [1-13C]Pyruvate MRI Multicenter Reproducibility-Are Multicenter Trials Feasible? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Metabolic imaging in the anesthetized rat brain using hyperpolarized [1-13C] pyruvate and [1-13C] ethyl pyruvate. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Dynamic volumetric hyperpolarized 13 C imaging with multi-echo EPI. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Kinetic analysis of multi-resolution hyperpolarized 13 C human brain MRI to study cerebral metabolism. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

In vivo 13C spectroscopy in the rat brain using hyperpolarized [1-(13)C]pyruvate and [2-(13)C]pyruvate. [2021]