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Metabolic Imaging for Brain Cancer

N/A

Recruiting

Led By Martin Pike, Ph.D.

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

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

Must have

* Adult patients (greater than 18 years of age) with glioma who require MRI and ¹⁸FDG-PET imaging

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial develops a new imaging technique to diagnose and evaluate neurological disease using MRI and glucose.

Who is the study for?

This trial is for adults over 18 with gliomas needing MRI and PET scans. It's not for those with sickle cell disease, uncertain pregnancy status, pregnant or breastfeeding women, people unable to consent, overweight beyond equipment limits, metallic/unsafe implants in the body, reduced kidney function (GFR < 45), other risky health conditions as judged by the investigator, poor vein access for IVs, serious illnesses like uncontrolled infections or diabetes type II that could affect study results or compliance.

What is being tested?

The trial is testing a new metabolic imaging technique called aMRI against the standard PET scan using fludeoxyglucose F-18 to see if it can effectively evaluate neurological diseases in glioma patients. The goal is to find out if this new method of analyzing MRI images can provide similar information about tumor metabolism as the more expensive and less available PET scans.

What are the potential side effects?

Potential side effects may include reactions to contrast agents used during MRI (gadoterate meglumine) such as nausea or itching; allergic reactions are possible but rare. For PET scans using fludeoxyglucose F-18 there might be discomfort at injection site or allergic reaction.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean values of kᵢₒ*V of the entire tumor region

Secondary study objectives

Mean value of kᵢₒ*V in the tumor periphery and core regions

kᵢₒ*V in different normal appearing brain sub-regions, unaffected by tumor

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: Diagnostic (¹⁸FDG PET, MRI)Experimental Treatment4 Interventions

Patients receive ¹⁸FDG IV, then 60 minutes later undergo simultaneous MRI and PET scanning. During this scanning period, patients will receive gadoterate meglumine IV to obtain post-contrast MRI. Total scanning time will take 45-60 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast-enhanced Magnetic Resonance Imaging

2005

Completed Phase 1

~320

Positron Emission Tomography

2011

Completed Phase 2

~2200