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Diagnostic Imaging

Metabolic MRI for Brain Tumor

Phase < 1

Recruiting

Led By Benjamin M Ellingson

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

AIM 2: Newly diagnosed or recurrent suspected or confirmed glioma (low or high grade), 10 IDH mutant and 10 IDH wild type gliomas, clinically indicated for resective surgery or biopsy, age 18+, tumor size > 1x1x1 cm (measurable)

AIM 1: Healthy volunteers with no evidence of brain tumors or neurologic disease, age 18+

Must not have

AIM 3: Cannot safely perform an MRI or use of MRI contrast agents, age < 18

AIM 2: Cannot safely perform an MRI or use of MRI contrast agents, age < 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new MRI sequence to better detect and diagnose brain tumors.

Who is the study for?

This trial is for adults over 18 with newly diagnosed or recurrent glioma, a type of brain tumor. Healthy volunteers are also needed for part of the study. Participants must be able to safely undergo MRI scans and have tumors measurable at least 1cm in size. Those receiving immunotherapy for recurrent glioma can join too.

What is being tested?

The trial is testing a new multinuclear metabolic MRI sequence designed to improve early detection, diagnosis, prognosis, and treatment planning in brain cancer patients. It involves biospecimen collection and diagnostic imaging using this novel technology.

What are the potential side effects?

Since the interventions involve non-invasive imaging techniques like MRI rather than drugs or surgery, side effects are minimal but may include discomfort from lying still during the scan or reactions to contrast agents if used.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 or older with a suspected or confirmed glioma, indicated for surgery, and my tumor is larger than 1cm³.

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I am over 18 and do not have any brain tumors or neurological diseases.

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I am 18 or older with recurrent glioma and am in an immunotherapy trial or need immunotherapy.

Exclusion Criteria

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

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I am under 18 or cannot safely have an MRI with contrast.

Select...

I am under 18 or cannot safely have an MRI with contrast.

Select...

I am under 18 and cannot safely have an MRI.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

NHE1 expression

Total sodium concentration

Tumor metabolism

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: Basic science (MRI, metabolic imaging, tissue collection)Experimental Treatment3 Interventions

AIM 1: Previous scan data from healthy subjects is collected and analyzed. AIM 2: Patients undergo MRI. Patients also undergo collection of tissue samples for IHC analysis. AIM 3: Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180