Advanced MRI Imaging for Glioblastoma

Recruiting in Palo Alto (17 mi)

Overseen byKunal S Patel, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Jonsson Comprehensive Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.

Research Team

Kunal S Patel, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

I have been diagnosed with a grade IV glioblastoma.

I am 18 years old or older.

Exclusion Criteria

I am under 18 years old.

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

I am not cleared for surgery by a doctor.

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Treatment Details

Interventions

Chemical Exchange Saturation Transfer Magnetic Resonance Imaging (Procedure)

Trial OverviewThe 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.

Participant Groups

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.