Only 0 spots left

~0 spots leftby Aug 2025

Metabolic MRI for Brain Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDirk Mayer, Dr. rer. nat.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Maryland, Baltimore

Disqualifiers: Inability to undergo MRI, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study. Up to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).

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 data supports the effectiveness of the treatment Hyperpolarized 13C-Pyruvate MRI for brain cancer?

Research shows that Hyperpolarized 13C-Pyruvate MRI can effectively highlight changes in tumor metabolism, which helps in assessing how well a brain tumor is responding to treatment. This technique has been used successfully in other cancers, like breast cancer, to track tumor metabolism and evaluate treatment responses.¹ ² ³ ⁴ ⁵

Is Hyperpolarized 13C-Pyruvate MRI safe for humans?

Studies have shown that Hyperpolarized 13C-Pyruvate MRI is safe and feasible in humans, including those with prostate cancer, and it has been used in research for various cancers and healthy volunteers without reported safety issues.¹ ² ⁶ ⁷ ⁸

How does the treatment in the Metabolic MRI for Brain Cancer trial differ from other treatments for brain cancer?

This treatment uses hyperpolarized 13C pyruvate MRI, a novel imaging technique that allows for the visualization of metabolic processes in brain tumors, providing unique insights into tumor metabolism that are not available with standard imaging methods. It can track the conversion of pyruvate to lactate, offering a potential biomarker for assessing tumor activity and response to treatment.¹ ² ⁶ ⁷ ⁹

Research Team

Dirk Mayer, Dr. rer. nat.

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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.

See 1 more

Exclusion Criteria

Inability to undergo MRI scan

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

Trial Timeline

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

Treatment Details

Interventions

Hyperpolarized 13C-Pyruvate (Metabolic Imaging Agent)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: metabolic MRIExperimental Treatment1 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

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

University of Maryland Medical CenterEllicott City, MD

Rosy Njonkou TchoquessiBaltimore, MD

Loading ...

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Patients Recruited

540,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperpolarized Carbon-13 MRI in Breast Cancer.Woitek, R., Brindle, KM.[2023]

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]

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]

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]

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]

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]

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]