Metabolic MRI for Brain Cancer

Recruiting at 1 trial location

Overseen By Rosy Njonkou Tchoquessi

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Maryland, Baltimore

Disqualifiers: Inability to undergo MRI, 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: 1

Duration: 1 week

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for diagnosing brain tumors using hyperpolarized metabolic MRI. It targets patients with specific brain tumors, known as gliomas, to determine if this method is safe and effective compared to standard MRI. The trial employs HP 13C-pyruvate (a form of hyperpolarized 13C-Pyruvate) to enhance MRI images. Individuals with a new or existing glioma who are scheduled for surgery might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative diagnostic approach.

Do I need to stop my current medications for the trial?

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 metabolic MRI is safe for diagnosing brain tumors?

Research has shown that using hyperpolarized 13C-pyruvate for imaging is safe. One study found that this substance did not cause major side effects when used for brain imaging. It also enhanced image quality, allowing doctors to see the brain more clearly.

Participants have tolerated this treatment well, which is promising for diagnosing brain tumors. However, as this is an early-stage trial, the primary goal is to ensure its safety for a broader population. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for glioma, a type of brain cancer, involve surgery, radiation, and chemotherapy to target and destroy cancer cells. However, researchers are excited about using hyperpolarized 13C-pyruvate in metabolic MRI because it offers a new way to visualize and understand the tumor's metabolism in real-time. This technique could provide unique insights into how the cancer is functioning and responding to treatments. Unlike traditional imaging methods, metabolic MRI with hyperpolarized 13C-pyruvate could potentially allow for safer and more detailed assessments of brain tumors, helping doctors make more informed treatment decisions.

What evidence suggests that hyperpolarized 13C-pyruvate MRI is effective for diagnosing brain tumors?

Research has shown that a special type of MRI, called hyperpolarized 13C-Pyruvate MRI, is very useful for examining brain tumors. Studies have found that it allows doctors to observe how the tumor uses energy, aiding in the detection of active tumors. It can also differentiate between various tumor types, providing more detailed information than regular MRI scans. This method is non-invasive, meaning it doesn't involve surgery or inserting anything into the body, and it helps doctors monitor brain cancer more effectively. In this trial, participants with gliomas will undergo metabolic MRI to evaluate the safety of hyperpolarized 13C-Pyruvate MRI in this population. These findings suggest that hyperpolarized 13C-Pyruvate MRI could be a valuable tool for diagnosing brain tumors like gliomas. ^{3 6 7 8 9}

Who Is on the Research Team?

Dirk Mayer, Dr. rer. nat.

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with a new or previously diagnosed infiltrating glioma, such as various grades of astrocytoma and oligodendroglioma. Participants must be able to have an MRI with contrast and not be pregnant. Those who can't undergo MRI scans or receive IV contrast due to severe reactions or poor kidney function cannot join.

Inclusion Criteria

I have a brain tumor suspected to be or confirmed as glioma and may need surgery.

Negative serum pregnancy test

I am between 18 and 80 years old.

Exclusion Criteria

Inability to undergo MRI scan

I cannot have IV contrast due to a severe reaction or kidney issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hyperpolarized metabolic MRI to assess safety and feasibility in diagnosing brain tumors

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized 13C-Pyruvate

Trial Overview

The study tests the safety and usefulness of hyperpolarized metabolic MRI using a substance called HP 13C-pyruvate in diagnosing brain tumors. It aims to see if this method is better than standard MRI imaging for patients with infiltrating gliomas.

How Is the Trial Designed?

Group I: metabolic MRI Experimental Treatment 1 Intervention

Single-arm study in patients who have Glioma Perform metabolic magnetic resonance imaging on patient have a Glioma cancer to understand if metabolic MRI can be safely performed on this population

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

This study is the first to use hyperpolarized 13C MRI to visualize and measure how the human brain processes [2-13C]pyruvate, providing insights into cerebral energy metabolism.

In a trial involving 5 healthy volunteers, the technique allowed for the simultaneous assessment of glycolytic and oxidative metabolism by quantifying the conversion rates of pyruvate to lactate and glutamate, highlighting its potential for advanced metabolic imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage. Chung, BT., Kim, Y., Gordon, JW., 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]

Metabolic imaging techniques, particularly hyperpolarized Magnetic Resonance (HP-MR), show promise in accurately assessing tumor metabolism and therapeutic responses in cancer treatment.

HP-MR has recently been translated into clinical practice, allowing for detailed measurements of 13C-pyruvate metabolism, which could enhance the evaluation of treatment efficacy compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Therapeutic Efficacy in Real-time by Hyperpolarized Magnetic Resonance Metabolic Imaging. Dutta, P., Salzillo, TC., Pudakalakatti, S., et al.[2023]

The study successfully developed a combined hyperpolarized 13C pyruvate and urea MRI technique, which allows for simultaneous assessment of cancer metabolism and tissue perfusion, showing promising results for clinical translation.

Toxicology studies confirmed the safety of the combined probe, and the imaging achieved adequate spatial and temporal resolution, paving the way for the first-in-human dual-agent hyperpolarized MRI study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical translation of hyperpolarized 13 C pyruvate and urea MRI for simultaneous metabolic and perfusion imaging. Qin, H., Tang, S., Riselli, AM., et al.[2022]

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, 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]

Hyperpolarized MRI using [1-13C] pyruvate can effectively characterize energy metabolism in the human brain and identify altered cancer metabolism in brain tumors, as evidenced by the production of HP lactate from HP pyruvate.

This method shows promise as a quantitative metabolic biomarker for assessing tumor response, correlating well with standard clinical imaging techniques like MRI and PET/CT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Imaging of the Human Brain with Hyperpolarized 13C Pyruvate Demonstrates 13C Lactate Production in Brain Tumor Patients. Miloushev, VZ., Granlund, KL., Boltyanskiy, R., et al.[2019]

Hyperpolarized carbon-13 MRI (HP-13C MRI) showed consistent measurements of brain metabolism in both healthy volunteers and patients with diffuse infiltrating glioma, indicating its potential as a reliable non-invasive imaging technique for monitoring brain tumor treatment.

In patients treated with the anti-angiogenic agent bevacizumab, there were significant increases in metabolic rates (kPL and kPB) in normal-appearing white matter, while progressive disease was associated with elevated kPL in tumor lesions, suggesting that HP-13C MRI can detect metabolic changes related to tumor progression and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of serial hyperpolarized 13C metabolic imaging in patients with glioma. Autry, AW., Gordon, JW., Chen, HY., et al.[2021]

This study successfully used MR spectroscopic imaging of hyperpolarized [2-(13)C]pyruvate to visualize metabolic changes in glioma-bearing rat brains, revealing higher lactate and lower glutamate levels in tumors compared to normal brain tissue.

Administration of dichloroacetate increased glutamate levels in both tumor and normal brain tissue, indicating its potential to modulate mitochondrial metabolism in gliomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric spiral chemical shift imaging of hyperpolarized [2-(13) c]pyruvate in a rat c6 glioma model. Park, JM., Josan, S., Jang, T., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Metabolic Imaging of the Human Brain with Hyperpolarized ...

Here we present the first dynamically acquired human brain HP 13C metabolic spectra and spatial metabolite maps in cases of both untreated and recurrent tumors.

2.

aacrjournals.org

aacrjournals.org/cancerres/article/78/14/3755/631786/Metabolic-Imaging-of-the-Human-Brain-with

Metabolic Imaging of the Human Brain with Hyperpolarized 13 ...

Hyperpolarized pyruvate MRI enables metabolic imaging in the brain and can be a quantitative biomarker for active tumors.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213158220301601

Characterization of serial hyperpolarized 13C metabolic ...

Hyperpolarized carbon-13 (HP-13C) MRI is a non-invasive imaging technique for probing brain metabolism, which may improve clinical cancer surveillance.

4.

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 ...

5.

pubs.rsna.org

pubs.rsna.org/doi/full/10.1148/rycan.230005

Hyperpolarized Carbon 13 MRI: Clinical Applications and ...

Clinical results have now demonstrated that hyperpolarized [1-13C]pyruvate MRI findings can stratify tumors according to grade, with higher ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10814348/

Advanced Hyperpolarized 13C Metabolic Imaging Protocol for ...

This study aimed to implement a multimodal 1H/HP-13C imaging protocol to augment the serial monitoring of patients with glioma, while ...

7.

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.

8.

nature.com

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

Hyperpolarized 13 C-pyruvate MRI detects real-time ...

HP 13 C-pyruvate MRI can detect real-time glycolytic metabolism within prostate cancer metastases, and can measure changes in quantitative k PL values ...

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S1053811923005013

Hyperpolarized [2–13C]pyruvate MR molecular imaging ...

Hyperpolarized (HP) 13 C Magnetic Resonance Imaging (MRI) was applied for the first time to image and quantify the uptake and metabolism of [2– 13 C]pyruvate ...