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ASL-MRI for Glioblastoma Treatment Assessment

N/A

Waitlist Available

Led By Ananth Madhuranthakam, PhD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Scheduled to undergo chemoradiation

Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

Must not have

Patients with uncontrollable claustrophobia, severe lower back pain, and uncontrollable tremors, to the point that it would render them unable to tolerate an MRI study.

Subjects who have had prior chemotherapy or radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will use MRI to study how well a treatment for glioblastoma works.

Who is the study for?

This trial is for patients with newly diagnosed Glioblastoma (GBM) who haven't started treatment. They must be in good enough health to perform daily activities, not have severe allergies to MRI contrast agents, and women must not be pregnant. It's also important that participants don't have any metal devices or conditions that make MRI unsafe.

What is being tested?

The study tests how well a special type of MRI scan called Arterial Spin Labeling (ASL) can track the effectiveness of GBM treatments over time. Participants will undergo seven additional ASL-MRI scans before, during, and after their standard therapy to monitor changes in brain perfusion.

What are the potential side effects?

MRI with ASL is generally safe but may cause discomfort due to the length of time spent in the scanner. There's a small risk of allergic reaction to gadolinium if used, though this trial avoids it. Claustrophobia or back pain could worsen due to lying still during scanning.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for combined chemotherapy and radiation treatment.

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I am able to care for myself and perform daily activities.

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I have been diagnosed with glioblastoma multiforme (GBM).

Exclusion Criteria

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

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I cannot undergo an MRI due to severe claustrophobia, back pain, or uncontrollable tremors.

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I have had chemotherapy or radiotherapy before.

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I am not pregnant.

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I have sickle cell disease or another condition that causes low red blood cell count.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Change in perfusion within enhancing tumor

Progression Free Survival (PFS)

Secondary study objectives

ASL measured perfusion within enhancing tumor

Overall Survival (OS)

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: Glioblastoma PatientsExperimental Treatment1 Intervention

Patients with histologically proven glioblastoma will undergo enhanced MRI with arterial spin labeling at weeks 0, 3, 6, 10, 18, 26, and 34 after beginning standard of care treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRI with Arterial Spin Labeling (ASL)

2019

N/A

~50

0 / 7Eligibility criteria met