Hyperpolarized MRI for Meningioma

Overseen By Wendy Ma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Javier Villaneuva-Meyer, MD

Disqualifiers: Heart failure, Myocardial infarction, Uncontrolled hypertension, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method using hyperpolarized carbon C 13 pyruvate to better understand and evaluate the behavior of meningiomas, a type of brain tumor. The aim is to determine if this method can help doctors assess tumor aggressiveness without surgery. Participants will receive an MRI scan with this new imaging agent and undergo safety monitoring. This trial may suit those diagnosed with a meningioma that appears clearly on MRI scans and who plan surgery within four weeks. As a Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants the chance to be among the first to benefit from this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have uncontrolled blood pressure despite medication, you may not be eligible to participate.

What prior data suggests that hyperpolarized 13C pyruvate is safe for use in MRI procedures?

Research has shown that hyperpolarized carbon C 13 pyruvate was generally safe in earlier studies. Most participants tolerated the treatment well, and serious side effects were uncommon. Patients received this treatment to collect imaging data on brain tumors, similar to its use in the current meningioma trial. Safety checks in these studies included monitoring vital signs and symptoms.

As an early-phase trial, the main focus is on safety. Such trials ensure the treatment does not harm participants. Testing in humans suggests that earlier lab results were promising enough to proceed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Most treatments for meningioma focus on surgical removal or radiation therapy. However, this new technique using hyperpolarized carbon C 13 pyruvate is distinct because it employs a novel imaging method that enhances MRI scans. This approach provides a clearer picture of the tumor's metabolism in real-time, offering insights that traditional imaging cannot. Researchers are excited because this could lead to more precise treatment planning and a better understanding of how the tumor responds to therapy, potentially improving outcomes for patients.

What evidence suggests that hyperpolarized MRI is effective for meningioma?

This trial will use hyperpolarized carbon C 13 pyruvate with MRI to study meningiomas. Research has shown that hyperpolarized carbon C 13 pyruvate helps doctors understand the function of brain tumors, such as meningiomas. This technique enhances certain body areas during MRI scans, providing clearer images of tumor activity. Studies have found that it successfully reveals tumor activity and any changes. This could help doctors assess tumor aggressiveness without surgery. Early findings suggest it is a promising tool for understanding and potentially managing brain tumors. ^{2 5 6 7 8}

Who Is on the Research Team?

Javier Villanueva-Meyer, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults (18+) with confirmed or presumed meningioma based on MRI scans can join this trial. They should have a life expectancy over 12 weeks, be able to give informed consent, and not have any health issues that would interfere with the study. Pregnant or breastfeeding women are excluded, as well as those with recent heart problems, uncontrolled blood pressure, other cancers within the last 3 years, or an inability to follow study procedures.

Inclusion Criteria

Participants must sign an informed consent indicating that they are aware of the investigational nature of this study

Participants cannot have contraindication to MRI examinations

Patients must sign an authorization for the release of their protected health information

Exclusion Criteria

I have moderate to severe heart failure.

I don't have any severe illnesses that my doctor thinks could interfere with this study.

I've been cancer-free and off treatment for any other cancer than non-melanoma skin cancer or cervical carcinoma in-situ for at least 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants receive a single research MR imaging using HP 13C pyruvate, intravenously injected, followed by safety monitoring

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging procedure, with clinical data obtained from medical records

30 days

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Hyperpolarized carbon C 13 pyruvate
• Magnetic Resonance Image (MRI)
• Saline

Trial Overview The trial is testing a new imaging technique using hyperpolarized carbon C 13 pyruvate injections followed by MRI scans. This method aims to better understand meningioma metabolism and identify aggressive tumor behavior without invasive procedures.

How Is the Trial Designed?

Group I: Hyperpolarized 13C pyruvate, Magnetic Resonance Imaging Experimental Treatment 3 Interventions

Participants will receive a single research MR imaging using HP 13C pyruvate, intravenously injected at a rate of 5 ml/second followed by a 20-ml saline flush at 5 ml/second. Safety monitoring, including vital signs and symptom monitoring will be performed for 30 minutes after dosing is completed, 1 to 3 days after dosing, and up to 30 days post scanning procedure. During the follow-up period, study personnel will obtain clinical data from the participants' medical records.

Hyperpolarized carbon C 13 pyruvate is already approved in United States for the following indications:

Approved in United States as Hyperpolarized 13C Pyruvate for:

• Research use only, not approved for clinical use

Who Is Running the Clinical Trial?

Javier Villaneuva-Meyer, MD

Lead Sponsor

Trials

1

Recruited

30+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

General Electric

Industry Sponsor

Trials

47

Recruited

12,400+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

The study demonstrated that hyperpolarized carbon-13 (HP-13C) metabolic imaging is safe and well-tolerated in pediatric patients with brain tumors, with no adverse events reported during the imaging process.

HP-13C imaging successfully showed the brain's metabolism of HP [1-13C]pyruvate, indicating its potential as a useful tool for assessing metabolic changes in pediatric CNS tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of Hyperpolarized 13C Metabolic Imaging in Pediatric Patients with Diffuse Intrinsic Pontine Glioma and Other CNS Cancers. Autry, AW., Park, I., Kline, C., et al.[2022]

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]

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]

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]

High-resolution hyperpolarized 13C pyruvate MRI can effectively measure cerebral perfusion in the human brain, showing significant positive correlations with traditional arterial spin labeling (ASL) methods across different brain regions.

This study, involving five healthy volunteers, demonstrates that hyperpolarized pyruvate MRI not only provides detailed spatial imaging of brain structures but also allows for simultaneous assessment of cerebral metabolism and perfusion, enhancing our understanding of brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating cerebral perfusion with high resolution hyperpolarized [1-13 C]pyruvate MRI. Hu, JY., Vaziri, S., Bøgh, N., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06014905

Feasibility of Acquiring Hyperpolarized Imaging in Patients ... This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data ...

2. 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 ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05550

Hyperpolarized Carbon 13 Pyruvate with Magnetic ... This phase I trial evaluates new scanning technique hyperpolarized carbon 13 pyruvate (hyperpolarized 13C pyruvate) with magnetic resonance spectroscopic ...

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

Hyperpolarized Pyruvate (13C) Injection Hyperpolarized Carbon C 13 Pyruvate in. Diagnosing Glioma in Patients with Brain. Tumors. Recruiting. Primary Brain Neoplasm. M D Anderson Cancer. Center, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37634883/

13 C]pyruvate MR molecular imaging with whole brain coverage 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06014905

Feasibility of Acquiring Hyperpolarized Imaging in Patients ... This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data ...

7. 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.

8. mdpi.com mdpi.com/2072-6694/16/2/354

Advanced Hyperpolarized 13C Metabolic Imaging Protocol ... This study aimed to implement a multimodal 1 H/HP- 13 C imaging protocol to augment the serial monitoring of patients with glioma.