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Advanced Imaging Techniques for Glioblastoma (GABLE Trial)

Phase 2

Recruiting

Led By Daniel P Barboriak

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patient must be ≥ 18 years of age

Patient must have a Karnofsky Performance Status ≥ 60%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from biomarker collection to death due to any cause, assessed up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is trying to figure out if using different imaging techniques can give doctors better information about tumors in patients with newly diagnosed brain cancer. The current standard is using magnetic resonance imaging (MRI), but this

Who is the study for?

This trial is for adults over 18 with newly diagnosed glioblastoma (GBM), confirmed by pathology and who have had surgery within the last 7 weeks. Participants must be in good enough health to perform daily activities (Karnofsky Performance Status ≥ 60%) and plan to receive standard GBM treatment. They should have completed certain MRIs, not be allergic to imaging agents, and able to tolerate MRI procedures.

What is being tested?

The study tests if advanced brain scan techniques like Fluciclovine F18 PET scans, Dynamic Susceptibility Contrast-Enhanced MRI, Gadolinium-Chelate enhanced images, and Magnetic Resonance Spectroscopy can more accurately assess tumor activity in patients with new glioblastoma compared to usual MRI methods.

What are the potential side effects?

Since this trial focuses on imaging techniques rather than drugs, side effects may include discomfort during scans or reactions to contrast agents used for MRI or PET scans such as mild pain, swelling at the injection site or rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am mostly able to care for myself but may need occasional help.

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I have a new diagnosis of GBM that is IDH wild type, confirmed by tests.

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I am planning to receive standard treatment for newly diagnosed brain cancer.

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My MGMT methylation status is being tested.

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I have completed an MRI before my brain tumor surgery and can upload the images.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from biomarker collection to death due to any cause, assessed up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from biomarker collection to death due to any cause, assessed up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from biomarker collection to death due to any cause, assessed up to 6 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

Event free survival (EFS)

Overall survival (OS)

Secondary study objectives

True disease progression and pseudo-progression (PsP)

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 (DSC-MRI, fluciclovine F18 PET, MR spectroscopy)Experimental Treatment5 Interventions

Patients receive a gadolinium-based contrast agent and undergo DSC-MRI scans at 4 and 8 weeks after completion of SOC radiation therapy. Patients with evidence of disease progression then undergo MR spectroscopy or receive fluciclovine F18 IV and undergo PET scan within 12 weeks of SOC radiation therapy completion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

2006

Completed Early Phase 1

~220

Positron Emission Tomography

2011

Completed Phase 2

~2200