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Procedure

Advanced MRI Imaging for Glioblastoma

Phase 3

Waitlist Available

Led By Kunal S Patel

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

Documentation of a newly diagnosed World Health Organization (WHO) grade IV glioblastoma as evidenced by clinical features and imaging data

Be older than 18 years old

Must not have

Male or female < 18 years of age

Not medically cleared for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing a new type of MRI imaging called pH weighted chemical exchange saturation transfer (CEST) MRI to the standard MRI imaging for guiding surgical resections in patients with glioblastoma.

Who is the study for?

This trial is for patients with glioblastoma, a type of brain cancer. It's testing if a new MRI technique can help surgeons remove more of the tumor than standard surgery does. Participants should be eligible for surgical resection and meet specific health criteria not detailed here.

What is being tested?

The study compares traditional MRI-guided surgery to pH weighted Chemical Exchange Saturation Transfer (CEST) MRI-based surgery in removing glioblastoma tumors. The goal is to see if CEST MRI can better identify and allow removal of tumor tissue that regular MRIs might miss.

What are the potential side effects?

Since this trial focuses on imaging techniques rather than drugs, side effects are related to the surgical procedure itself or potential reactions to contrast agents used during MRI scans.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a grade IV glioblastoma.

Exclusion Criteria

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

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I am under 18 years old.

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I am not cleared for surgery by a doctor.

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I have had cancer treatment before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Progression free survival

Secondary study objectives

Overall survival

Quality of life

Surgical complication rate

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group II (CEST MRI based surgical resection)Experimental Treatment5 Interventions

Patients undergo surgical resection with intraoperative guidance using CEST MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up.

Group II: Group I (standard of care surgical resection)Active Control5 Interventions

Patients undergo surgical resection with standard intraoperative guidance using contrast-enhanced MRI. Patients also undergo post operative standard of care radiation therapy over 30 fractions and receive standard of care temozolomide PO for 6 weeks. Additionally, patients undergo MRI during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Surgical Procedure

2020

Completed Phase 2

~160

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180