Advanced MRI Imaging for Glioblastoma

Overseen By Kunal Patel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Under 18, Not surgery cleared, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

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.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since previous treatments like chemotherapy or radiation therapy are exclusion criteria, it's possible that some medications might need to be paused. Please consult with the trial team for specific guidance.

Is Chemical Exchange Saturation Transfer MRI safe for humans?

The research articles focus on the effectiveness of Chemical Exchange Saturation Transfer MRI in monitoring and predicting glioblastoma progression, but they do not provide specific safety data for humans. ^{1 2 3 4 5}

How is the treatment Chemical Exchange Saturation Transfer MRI different from other treatments for glioblastoma?

Chemical Exchange Saturation Transfer MRI (CEST-MRI) is unique because it uses advanced imaging to predict early tumor progression and monitor treatment response in glioblastoma patients. Unlike traditional imaging, CEST-MRI provides detailed information about cellular and metabolic changes, helping doctors assess how well the treatment is working sooner. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Chemical Exchange Saturation Transfer Magnetic Resonance Imaging for glioblastoma?

Research shows that Chemical Exchange Saturation Transfer MRI can predict early tumor progression in glioblastoma patients and monitor their response to standard treatments, helping to identify the earliest time point for therapeutic response. ^{1 2 4 5 6}

Who Is on the Research Team?

Kunal S Patel, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Resection

Patients undergo surgical resection with either standard intraoperative guidance using contrast-enhanced MRI or CEST MRI

1 week

Post-operative Treatment

Patients receive standard of care radiation therapy over 30 fractions and temozolomide orally for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at months 3, 6, 12, and 24

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

Trial Overview 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.

How Is the Trial Designed?

Group I: Group II (CEST MRI based surgical resection) Experimental Treatment 5 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 Control 5 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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Published Research Related to This Trial

CEST-MRI can identify early changes in glioblastoma (GBM) characteristics as soon as 2 weeks into standard chemoradiation treatment, helping to distinguish between patients whose tumors are progressing and those whose are not.

Baseline CEST metrics, such as MTRNOE and MTRAmide, can predict tumor progression even before treatment starts, suggesting that these imaging biomarkers could guide personalized treatment plans for GBM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Glioblastoma Response to Therapy With Chemical Exchange Saturation Transfer. Mehrabian, H., Myrehaug, S., Soliman, H., et al.[2019]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Grading of gliomas using 3D CEST imaging with compressed sensing and sensitivity encoding. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Chemical exchange saturation transfer MRI serves as predictor of early progression in glioblastoma patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Glioblastoma Response to Therapy With Chemical Exchange Saturation Transfer. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A nano-sized PARACEST-fluorescence imaging contrast agent facilitates and validates in vivo CEST MRI detection of glioma. [2021]

5. England pubmed.ncbi.nlm.nih.gov

pH-Weighted Amine Chemical Exchange Saturation Transfer Echo Planar Imaging (CEST-EPI) Visualizes Infiltrating Glioblastoma Cells. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Glutamate-Weighted CEST Contrast After Removal of Magnetization Transfer Effect in Human Brain and Rat Brain with Tumor. [2021]