25 Participants Needed

Hyperpolarized MRI for Meningioma

WM
Overseen ByWendy Ma
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Javier Villaneuva-Meyer, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior

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 data supports the effectiveness of the treatment Hyperpolarized carbon C 13 pyruvate for meningioma?

Research shows that hyperpolarized carbon-13 MRI, which uses hyperpolarized pyruvate, can effectively track tumor metabolism in brain cancers by highlighting changes in energy use within the tumor. This technique has been used in other brain tumors to provide detailed metabolic information, suggesting it could be useful for assessing meningiomas as well.12345

Is hyperpolarized 13C pyruvate safe for humans?

Research has shown that hyperpolarized 13C pyruvate has been used safely in humans, including healthy volunteers and pediatric patients with brain tumors, to study metabolism without reported safety issues.12367

How is the treatment Hyperpolarized carbon C 13 pyruvate unique for meningioma?

Hyperpolarized carbon C 13 pyruvate is unique because it allows doctors to see how the tumor is using energy by tracking the conversion of pyruvate to other substances in the brain, providing detailed metabolic information that standard imaging techniques cannot offer.12358

Research Team

JV

Javier Villanueva-Meyer, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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
I am 18 years old or older.
See 5 more

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.
See 4 more

Timeline

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)

Treatment Details

Interventions

  • Hyperpolarized carbon C 13 pyruvate
  • Magnetic Resonance Image (MRI)
  • Saline
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Hyperpolarized 13C pyruvate, Magnetic Resonance ImagingExperimental Treatment3 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

Find a Clinic Near You

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+

Findings from Research

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.
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]
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.
Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage.Chung, BT., Kim, Y., Gordon, JW., et al.[2023]
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.
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]

References

Volumetric spiral chemical shift imaging of hyperpolarized [2-(13) c]pyruvate in a rat c6 glioma model. [2018]
Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage. [2023]
Pilot Study of Hyperpolarized 13C Metabolic Imaging in Pediatric Patients with Diffuse Intrinsic Pontine Glioma and Other CNS Cancers. [2022]
Hyperpolarized Carbon-13 MRI in Breast Cancer. [2023]
Metabolic Imaging of the Human Brain with Hyperpolarized 13C Pyruvate Demonstrates 13C Lactate Production in Brain Tumor Patients. [2019]
Hyperpolarized 13carbon MR. [2019]
Metabolic Imaging as a Biomarker of Early Radiation Response in Tumors. [2018]
Investigating cerebral perfusion with high resolution hyperpolarized [1-13 C]pyruvate MRI. [2023]