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Metabolic MRI for Brain Cancer

Phase 1

Recruiting

Led By Dirk Mayer, Dr. rer. nat

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suitable to undergo contrast-enhanced MRI

Be older than 18 years old

Must not have

Inability to receive IV contrast secondary to severe reaction or renal insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within three years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and feasibility of using hyperpolarized metabolic MRI to diagnose brain tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on diagnostic imaging rather than medication, side effects may include typical risks associated with MRIs like discomfort from lying still and loud noises during the scan, plus any potential reaction to the IV contrast used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can safely have an MRI with contrast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within three years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within three years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within three years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of metabolic MRI to diagnose Glioma

Secondary study objectives

Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 2Eligibility criteria met