Hyperpolarized Pyruvate Imaging for Cancer

Recruiting at 1 trial location

Overseen By Vesselin Miloushev, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Breastfeeding, Claustrophobia, Hepatic, Renal, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

109 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using MRI scans with a special imaging agent called hyperpolarized pyruvate. Researchers aim to determine if these scans consistently reproduce results and provide additional information on cancer behavior in the body. It targets patients with certain solid tumors, such as sarcoma or breast cancer, who can safely undergo MRI scans. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could improve cancer imaging techniques.

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 trial coordinators or your doctor.

What prior data suggests that hyperpolarized pyruvate imaging is safe for patients with solid tumors?

Studies have shown that hyperpolarized pyruvate is generally safe for people. Research using hyperpolarized [1-13C]pyruvate as an imaging tool indicates it is well-tolerated. One study found that using this substance in imaging provided important information without major side effects. Another source confirmed its safety when injected at certain concentrations. Overall, these findings suggest that hyperpolarized pyruvate is a safe choice for imaging tests. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperpolarized pyruvate imaging for cancer because it offers a new way to visualize tumors in the body with remarkable precision. Unlike traditional imaging techniques, this method uses a special form of pyruvate that is hyperpolarized, allowing it to more clearly highlight metabolic activity within cancer cells. This could lead to better monitoring of how tumors respond to treatments in real-time, potentially aiding in quicker and more effective treatment adjustments. Additionally, it opens up the possibility of detecting tumors earlier and with greater accuracy compared to current imaging options.

What evidence suggests that hyperpolarized pyruvate MRI is effective for cancer imaging?

Research shows that hyperpolarized pyruvate holds promise for cancer imaging. Studies have found it can detect metabolic changes in tumors that traditional methods might miss, offering insights into tumor behavior at a cellular level. Early findings suggest it could serve as a metabolic biomarker, indicating disease presence or progress. It has proven particularly helpful in evaluating tumor response in prostate and brain cancer. This trial will assess the reproducibility of hyperpolarized pyruvate MRI in patients with solid tumors, potentially providing new insights into diagnosing and monitoring cancer treatment. ^{2 5 6 7 8}

Who Is on the Research Team?

Kayvan Keshari, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with certain cancers (sarcoma, prostate, breast, brain, metastatic or pancreatic) who can undergo MRI scans. They must not be pregnant or breastfeeding and should have a tumor that's measurable. People with severe liver or kidney issues, major illnesses like unstable heart conditions, or those who cannot tolerate an MRI due to devices like pacemakers are excluded.

Inclusion Criteria

My cancer diagnosis was confirmed by a pathology department, or I have suspected brain cancer based on MRI.

My cancer can be measured or seen on scans, with a tumor larger than 1cm.

I am not pregnant, confirmed by a recent test.

Exclusion Criteria

I cannot or will not have an IV line placed for a pyruvate injection.

Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient

I do not have any severe illnesses like heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo two hyperpolarized MRI scans to assess reproducibility

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized Pyruvate

Trial Overview The study tests the reliability of hyperpolarized [1-13C] pyruvate (HP) in MRI scans for cancer patients by conducting two HP-MRI scans to see if they produce consistent results each time. It also compares these images with surgical pathology to check if it offers extra details on disease metabolism.

How Is the Trial Designed?

Group I: Hyperpolarized Pyruvate MRI Reproducibility Experimental Treatment 1 Intervention

This is a reproducibility study of hyperpolarized \[1-13C\] pyruvate MRI in patients with solid tumors. A total of 100 patients will be enrolled, 50 of whom will be imaged using 1D MR spectroscopy and the other 50 with 3D imaging sequence.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The study successfully hyperpolarized [1,2-13C]pyruvate with approximately 7% polarization, allowing for enhanced monitoring of its conversion to lactate in cancer cells using a new pulse sequence called MINERVA.

This method enables simultaneous observation of different chemical reactions and the detection of reaction intermediates, such as 2-hydroperoxy-2-hydroxypropanoate, in real time, which could improve our understanding of metabolic processes in cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Pyruvate Chemical Conversion Monitoring Enabled by PHIP. Stevanato, G., Ding, Y., Mamone, S., et al.[2023]

Hyperpolarized 13C-MRI, which enhances the detection of tumor metabolism by 4-5 orders of magnitude, can track the metabolism of hyperpolarized [1-13C]pyruvate in cancer patients, providing insights into tumor activity and response to treatment.

Combining HP 13C-MRI with traditional 1H-MRI allows for detailed anatomical imaging and functional tumor analysis, potentially enabling early identification of patients who are not responding to therapies, although cost and technical challenges need to be addressed for broader clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer. Woitek, R., Brindle, KM.[2023]

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]

Hyperpolarized carbon-13 (13C) MRI is a groundbreaking imaging technique that allows for real-time, noninvasive observation of metabolic processes in diseases like cancer and cardiovascular conditions, which were previously difficult to study.

The review highlights the promising clinical applications of HP [1-13C]pyruvate MRI, suggesting it could enhance our understanding of metabolism, improve disease diagnosis, and speed up treatment evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C MRI: State of the Art and Future Directions. Wang, ZJ., Ohliger, MA., Larson, PEZ., et al.[2020]

Hyperpolarized (HP) (13)C labeled compounds, particularly HP 1-(13)C pyruvate, are effective MR contrast agents that allow for real-time investigation of metabolic pathways in vivo, with the ability to track pyruvate metabolism for nearly 2 minutes post-injection.

The technique has expanded beyond tumor metabolism to non-invasively assess physiological parameters like pH, highlighting its growing potential in medical research, especially with the increasing availability of dynamic nuclear polarization (DNP) systems for generating hyperpolarized materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13carbon MR. Rowland, IJ., Peterson, ET., Gordon, JW., et al.[2019]

The study introduces a new method, PHIP-SAH, for hyperpolarizing [1-13 C]pyruvate, which allows for real-time monitoring of metabolic processes in cancer research, particularly in glycolytic pathways.

Using this method, researchers successfully applied hyperpolarized [1-13 C]pyruvate to investigate glycolysis in two breast cancer cell lines, validating their findings with traditional biochemical assays, indicating its potential for broader cancer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Studies of Tumor Cells Using [1-13 C] Pyruvate Hyperpolarized by Means of PHIP-Side Arm Hydrogenation. Cavallari, E., Carrera, C., Aime, S., et al.[2019]

In a study involving 17 canine cancer patients, hyperpolarized 13C Magnetic Resonance Spectroscopy (MRS) showed significant correlations between pyruvate-to-lactate conversion and 18F-FDG uptake specifically in sarcoma patients, suggesting a link between lactate generation and cancer metabolism.

The research indicates that the relationship between lactate production and 18F-FDG uptake varies by cancer type, with sarcoma patients exhibiting higher lactate generation relative to 18F-FDG uptake compared to carcinoma patients, which could enhance the understanding of cancer metabolism and improve diagnostic imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined hyperpolarized 13C-pyruvate MRS and 18F-FDG PET (hyperPET) estimates of glycolysis in canine cancer patients. Hansen, AE., Gutte, H., Holst, P., et al.[2019]

Hyperpolarized 13C-labelled cell substrates, like hyperpolarized pyruvate, could revolutionize anatomic imaging in oncology by providing new metabolic metrics for assessing treatment responses.

This imaging technique offers a more personalized approach to evaluating patients at different stages of cancer treatment, potentially improving clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic nuclear polarisation: The future of imaging in oncology? Serrao, EM., Brindle, KM.[2020]

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]

Hyperpolarised carbon-13 (13C)-MRI is a novel imaging technique that allows for dynamic imaging of tumor metabolism, particularly the conversion of [1-13C]pyruvate to [1-13C]lactate, which is relevant in cancer due to the Warburg effect.

Clinical studies have shown that hyperpolarised 13C-MRI can effectively differentiate between higher grade breast tumors and predict treatment responses to neoadjuvant chemotherapy by measuring early changes in 13C-label exchange.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarised 13C-MRI using 13C-pyruvate in breast cancer: A review. Arponen, O., Wodtke, P., Gallagher, FA., et al.[2023]

Hyperpolarized carbon 13 MRI (13C MRI) is a groundbreaking imaging technique that allows for real-time, noninvasive observation of tissue metabolism, particularly useful in cancer research.

This method has shown promise in clinical applications such as tumor grading, tailoring treatment based on metabolic profiles, and detecting early treatment responses by monitoring metabolic changes before structural alterations in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon 13 MRI: Clinical Applications and Future Directions in Oncology. Deen, SS., Rooney, C., Shinozaki, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7984723/

Hyperpolarized [1-13C]-Pyruvate Magnetic Resonance ... In this study, we demonstrate that hyperpolarized 13C-pyruvate MRSI detects metabolic differences in prostate tumor xenografts that are not detectable by steady ...

2. nature.com nature.com/articles/s41598-025-03454-1

Hyperpolarized [1- 13 C]pyruvate NMR spectroscopy ... These findings suggest that HP [1- 13 C]pyruvate NMR spectroscopy may serve as a metabolic biomarker for early-phase tumorigenesis in vivo.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6050093/

Metabolic Imaging of the Human Brain with Hyperpolarized ... Our results suggest that HP 13C pyruvate-to-lactate conversion may be a viable metabolic biomarker for assessing tumor response. Introduction. Current “open- ...

4. dctd.cancer.gov dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/13c-pyruvate-ib.pdf

Hyperpolarized Pyruvate (13C) Injection The applications have remained focused on cancer patients, with prostate, brain and other solid tumors, but cardiology with about 22% of all studies has ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04698564

Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic ... To study the accuracy of hyperpolarized metabolic MRI to diagnose prostate cancer. Compare the prediction of cancer from the MRI scan compared to actual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4201045/

Metabolic Imaging of Patients with Prostate Cancer Using ... This first-in-man imaging study evaluated the safety and feasibility of hyperpolarized [1-13C]pyruvate as an agent for noninvasively characterizing alterations ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03933670

Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring ... This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666441024000207

Dual hyperpolarized [1-13C]pyruvate and [13C]urea ... The novel addition of hyperpolarized [13C]urea data showed a significant mismatch between intra-tumoral metabolism and tissue perfusion in high grade cancer.