HP Pyruvate MRI for Cancer Detection

(HC-MRI Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Maryland, Baltimore

Disqualifiers: No tumor diagnosis

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: Unknown

Duration: 18-36 months

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to detect and understand different types of cancer. It uses a special MRI to observe how cancer cells use energy differently from normal cells. Participants receive an injection of hyperpolarized 13C-pyruvate, which highlights how cancer cells process energy. Individuals diagnosed with a tumor and scheduled for MRI appointments might be suitable for this trial. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in cancer detection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that hyperpolarized 13C pyruvate MRI is safe for cancer detection?

Research has shown that using hyperpolarized 13C-pyruvate in MRI scans is generally safe for people. In one study with prostate cancer patients, this method proved safe and useful for imaging. It helps doctors see how cancer cells use energy, improving their ability to find and understand tumors.

Another study demonstrated that using hyperpolarized 13C-pyruvate in brain scans was safe and enhanced image clarity. This suggests potential effectiveness in other parts of the body as well.

Overall, research supports the safety of hyperpolarized 13C-pyruvate in humans, making it a promising tool for detecting cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of hyperpolarized 13C-pyruvate in MRI for cancer detection because it offers a unique way to visualize metabolic activity within tumors. Unlike standard imaging methods, which primarily focus on anatomical changes, this technique provides real-time insights into how cancer cells process nutrients. This can potentially lead to earlier and more accurate detection of cancerous tissues. Moreover, the use of hyperpolarized compounds significantly enhances the MRI signal, allowing for sharper and more detailed images. This could revolutionize how we detect and monitor cancer, offering a new layer of information that current methods can't provide.

What evidence suggests that hyperpolarized 13C pyruvate MRI is effective for cancer detection?

Research has shown that hyperpolarized 13C-pyruvate MRI can effectively detect and analyze tumors by highlighting changes in energy usage. This technology uses a unique form of carbon (13C) attached to pyruvate, a substance involved in the body's energy production. Studies have found that cancer cells use glucose differently than normal cells, often converting more pyruvate into lactate. Hyperpolarized 13C MRI can track this change, aiding in tumor identification. Early results suggest that this method significantly enhances the ability to see and understand tumor behavior compared to standard imaging techniques. Although still in the early stages, this technique shows promise for improving cancer detection accuracy. Participants in this trial will receive an injection of hyperpolarized 13C-pyruvate and undergo HP-MR imaging to evaluate its effectiveness in cancer detection. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients who already have scheduled MR imaging appointments, can safely undergo an MRI scan, and have a clinical diagnosis of a tumor. It's not open to individuals without a tumor diagnosis.

Inclusion Criteria

I have been diagnosed with a tumor.

Patients with pre-existing MR imaging appointments

Must be able to undergo MR

Exclusion Criteria

I have not been diagnosed with a tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an injection of 250 mM of hyperpolarized 13-C pyruvate intravenously and undergo HP-MR imaging

18-36 months

Follow-up

Participants are monitored for imaging quality and metabolic changes after treatment

12-42 months

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 13C-Pyruvate

Trial Overview The study tests if hyperpolarized 13C pyruvate MRI can image various cancers by tracking the conversion of pyruvate to lactate—a process that's more active in cancer cells due to altered metabolism known as the Warburg effect.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Participants will receive an injection of 250 mM of hyperpolarized 13-C pyruvate intravenously after standard of care imaging sequences are performed. Then participants will undergo HP-MR imaging.

Hyperpolarized 13C-Pyruvate is already approved in United States, European Union for the following indications:

Approved in United States as Hyperpolarized 13C Pyruvate MRI for:

• Prostate cancer
• Research use in various cancers

Approved in European Union as Hyperpolarized 13C Pyruvate MRI for:

• Research use in various cancers

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

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]

Hyperpolarized (HP) 13C metabolic imaging is emerging as a promising clinical diagnostic tool for cancer, leveraging the unique metabolic changes in cancer cells to detect and monitor tumors.

The effectiveness of HP 13C MRI relies on advancements in MRI technology and pulse sequence design to optimize the detection of HP signals, particularly focusing on the use of HP pyruvate to identify lactate pools linked to cancer metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer in the crosshairs: targeting cancer metabolism with hyperpolarized carbon-13 MRI technology. von Morze, C., Merritt, ME.[2023]

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]

A new method using para-hydrogen allows for the rapid hyperpolarization of 13C-labeled substrates, achieving a polarization level of 24% for a precursor and 8% for free [1-13C]pyruvate, which significantly enhances magnetic resonance signals.

This technique enables real-time monitoring of metabolic processes, such as the conversion of pyruvate to lactate in cancer cells, highlighting its potential for advancing biomedical research and applications in magnetic resonance imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Field-Independent Method for the Rapid Generation of Hyperpolarized [1-13 C]Pyruvate in Clean Water Solutions for Biomedical Applications. Mamone, S., Jagtap, AP., Korchak, S., et al.[2022]

The study introduces a new method called Signal Amplification By Reversible Exchange (SABRE) that allows for the rapid production of hyperpolarized pyruvate for MRI, achieving results in just 6 minutes, making it a faster and more accessible option for metabolic imaging.

The produced hyperpolarized pyruvate solution is sterile, non-toxic, and pH neutral, indicating its safety for use in living organisms, which enhances its potential for diagnosing and monitoring cancer and other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vivo Metabolic Imaging of [1-13 C]Pyruvate-d3 Hyperpolarized By Reversible Exchange With Parahydrogen. de Maissin, H., Groß, PR., Mohiuddin, O., et al.[2023]

Hyperpolarized magnetic resonance imaging (HP-MRI) using (13)C-pyruvate is a promising tool for quantitatively assessing how solid tumors respond to radiotherapy and for monitoring potential toxicity in normal tissues.

This imaging technique can effectively predict responses related to metabolic changes in tumors, although there are still challenges to overcome for its successful use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Imaging as a Biomarker of Early Radiation Response in Tumors. Lai, SY., Fuller, CD., Bhattacharya, PK., et al.[2018]

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]

Nuclear Magnetic Resonance (NMR) can non-invasively detect and quantify metabolites in cells and tissues, revealing metabolic changes without destroying samples, although its sensitivity is traditionally low.

Recent advancements in hyperpolarization techniques, particularly ParaHydrogen Induced Polarization (PHIP), allow for a cost-effective and rapid increase in the detection sensitivity of metabolites like hyperpolarized pyruvate, which has been effectively used to study metabolic changes in prostate cancer cell lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-vitro NMR Studies of Prostate Tumor Cell Metabolism by Means of Hyperpolarized [1-13C]Pyruvate Obtained Using the PHIP-SAH Method. Cavallari, E., Carrera, C., Di Matteo, G., et al.[2020]

Hyperpolarized 13C MRI has shown promise in providing unique metabolic insights into cancer, with a dose-ranging study confirming its safety and feasibility in patients with prostate cancer.

Ongoing research is exploring the use of hyperpolarized agents in various cancer types, and advancements in technology and collaboration among academia, industry, and government are essential for translating this imaging technique into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized 13C MRI: Path to Clinical Translation in Oncology. Kurhanewicz, J., Vigneron, DB., Ardenkjaer-Larsen, JH., et al.[2023]

Hyperpolarized 13C MRI, particularly using [1-13C]pyruvate, is a promising technique for measuring localized metabolism in various diseases, including cancers and organ disorders, and has seen significant advancements in human studies over the past decade.

The paper outlines essential practices for conducting successful HP 13C MRI studies, covering preparation, MRI setup, data acquisition, and analysis, while also highlighting current evidence gaps and limitations in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Methods for Hyperpolarized [1-13C]pyruvate MRI Human Studies. Larson, PE., Bernard, JM., Bankson, JA., et al.[2023]

The study introduces a new method that allows for the detection of hyperpolarized [1-13C]pyruvate using standard proton-only MRI scanners, which could make this advanced imaging technique more accessible for clinical use.

By employing innovative pulse sequences to transfer hyperpolarization from carbon to protons, the method overcomes limitations related to specialized equipment, potentially enhancing the scalability of hyperpolarized MRI for diagnosing metabolic diseases like cancer and cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Robust Proton-Only Sensing of Hyperpolarized [1,2-13C2]-Pyruvate Using Broad-Spectral-Range Nuclear Magnetic Resonance Pulse Sequences. Mandzhieva, I., Adelabu, I., Nantogma, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6490043/

Hyperpolarized 13C MRI: State of the Art and Future Directions These results highlight the potential of this technology to improve tumor detection and characterization. The first results demonstrating metabolic response to ...

2. 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 ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mrm.29875

Current methods for hyperpolarized [1‐13C]pyruvate MRI ... MRI with hyperpolarized (HP) 13C agents, also known as HP 13C MRI, can measure processes such as localized metabolism that is altered in ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rycan.240004

Hyperpolarized 13 C Pyruvate MRI: An Important Window ... HP 13C pyruvate MRI has successfully been used in numerous preclinical cancer ... HP 13C pyruvate MRI results. The authors found that while ...

5. nature.com nature.com/articles/s41416-020-01224-6

The use of hyperpolarised 13C-MRI in clinical body ... The technique increases the signal-to-noise ratio for the detection of hyperpolarised 13C-labelled metabolites by several orders of magnitude ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6260457/

Hyperpolarized 13C MRI: Path to Clinical Translation in ... A dose-ranging study of HP [1-13C]pyruvate in patients with prostate cancer established safety and feasibility of this technique. Additional studies are ...

7. nature.com nature.com/articles/s41391-019-0180-z

Hyperpolarized 13 C-pyruvate MRI detects real-time ... HP 13C-pyruvate MRI can detect real-time glycolytic metabolism within prostate cancer metastases, and can measure changes in quantitative kPL ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38205934/

13 C]pyruvate in D 2 O for hyperpolarized MRI of the brain: A ... HP [1- 13 C]pyruvate in D 2 O is safe for human imaging and provides an increase in T 1 and SNR that may improve image quality.

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

Dual hyperpolarized [1-13C]pyruvate and [13C]urea ... Hyperpolarized [1-13C]pyruvate MRI was able to detect areas of clinically occult prostate cancer not seen on multiparametric MRI. •. The novel addition of ...