13 Participants Needed

Hyperpolarized C 13 Pyruvate Imaging for Brain Cancer

DS
Overseen ByDawid Schellingerhout
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
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 trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.

Do I need to stop my current medications to participate in 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 data supports the effectiveness of the treatment Hyperpolarized Carbon C 13 Pyruvate Imaging for Brain Cancer?

Research shows that hyperpolarized [1-13C]pyruvate can help detect treatment responses in brain tumors by highlighting changes in tumor metabolism, which is not easily visible with other imaging methods. This technique has been used to track tumor metabolism in both brain and breast cancer, suggesting its potential usefulness in monitoring how well treatments are working.12345

Is Hyperpolarized C 13 Pyruvate Imaging safe for humans?

Hyperpolarized C 13 Pyruvate Imaging has been used safely in studies with healthy human volunteers and brain tumor patients, showing no reported safety issues during the imaging process.16789

How does hyperpolarized C 13 pyruvate imaging differ from other brain cancer treatments?

Hyperpolarized C 13 pyruvate imaging is unique because it uses a special form of MRI to track the metabolism of pyruvate in real-time, providing detailed insights into tumor metabolism that other imaging methods can't offer due to high background signals in the brain. This technique allows for non-invasive monitoring of how brain tumors respond to treatments, which is not possible with standard imaging techniques.1491011

Research Team

Dawid Schellingerhout | MD Anderson ...

Dawid Schellingerhout

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with suspected or confirmed primary brain tumors who are candidates for tumor removal surgery. They must be able to undergo MRI scans and have a kidney function test (GFR) above 60. People with pacemakers, metal in their body, previous brain tumor treatments, or certain heart conditions cannot join.

Inclusion Criteria

Healthy volunteers should not have any issues with getting an MRI scan, but otherwise won't have any other requirements to participate.
You are going to have surgery to remove a suspected or confirmed primary brain tumor.
Written informed consent will be obtained from each participant including healthy volunteers
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Exclusion Criteria

Healthy volunteers will be screened using the same process but will otherwise not be subject to other selection criteria
You have a pacemaker or other metal devices in your body that are not safe for MRI scans.
The patient's anatomy makes it unsafe to do a specific type of biopsy.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hyperpolarized carbon C 13 pyruvate intravenously and undergo an MRSI scan

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day
1 visit (in-person)

Long-term follow-up

Participants' genomic, pathology, and imaging findings are assessed over time

Up to 1 year

Treatment Details

Interventions

  • Hyperpolarized Carbon C 13 Pyruvate
Trial OverviewResearchers are testing an imaging agent called hyperpolarized carbon C 13 pyruvate used before an advanced MRSI scan to see if it helps diagnose glioma more accurately in patients with brain tumors.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Diagnostic (carbon C 13 pyruvate, MRSI)Experimental Treatment2 Interventions
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Hyperpolarized [1-(13)C]pyruvate can effectively detect treatment responses in glioma tumors, which is challenging with traditional imaging methods like PET due to interference from normal brain tissue signals.
In a rat model, significant lactate labeling was observed in glioma tumors after treatment, with a notable decrease in the ratio of tumor lactate to blood pyruvate signal following whole brain irradiation, indicating a potential response to therapy.
Detecting response of rat C6 glioma tumors to radiotherapy using hyperpolarized [1- 13C]pyruvate and 13C magnetic resonance spectroscopic imaging.Day, SE., Kettunen, MI., Cherukuri, MK., et al.[2021]
In a study involving three patients with glioblastoma, 13C MR spectroscopic imaging using hyperpolarized pyruvate successfully detected increased lactate production in tumor regions prior to surgical resection, indicating altered metabolism in these aggressive tumors.
The imaging technique correlated well with histological findings, confirming the presence of WHO grade IV glioblastoma and suggesting that this method could help identify metabolic changes associated with tumor aggressiveness.
Preoperative imaging of glioblastoma patients using hyperpolarized 13C pyruvate: Potential role in clinical decision making.Chen, J., Patel, TR., Pinho, MC., et al.[2022]
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.
Characterization of serial hyperpolarized 13C metabolic imaging in patients with glioma.Autry, AW., Gordon, JW., Chen, HY., et al.[2021]

References

Detecting response of rat C6 glioma tumors to radiotherapy using hyperpolarized [1- 13C]pyruvate and 13C magnetic resonance spectroscopic imaging. [2021]
Preoperative imaging of glioblastoma patients using hyperpolarized 13C pyruvate: Potential role in clinical decision making. [2022]
Characterization of serial hyperpolarized 13C metabolic imaging in patients with glioma. [2021]
Hyperpolarized Carbon-13 MRI in Breast Cancer. [2023]
Combined hyperpolarized 13C-pyruvate MRS and 18F-FDG PET (hyperPET) estimates of glycolysis in canine cancer patients. [2019]
Hyperpolarized [2-13C]pyruvate MR molecular imaging with whole brain coverage. [2023]
Real-Time Pyruvate Chemical Conversion Monitoring Enabled by PHIP. [2023]
Metabolic Imaging of the Human Brain with Hyperpolarized 13C Pyruvate Demonstrates 13C Lactate Production in Brain Tumor Patients. [2019]
Hyperpolarized 13carbon MR. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Metabolic imaging in the anesthetized rat brain using hyperpolarized [1-13C] pyruvate and [1-13C] ethyl pyruvate. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Kinetic analysis of multi-resolution hyperpolarized 13 C human brain MRI to study cerebral metabolism. [2023]