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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new MRI technique called Chemical Exchange Saturation Transfer Magnetic Resonance Imaging (CEST MRI) to determine if it can better guide surgeons in removing glioblastoma, an aggressive brain tumor. The goal is to compare this method with the standard MRI during surgery to identify tumor tissue more effectively. Participants will be divided into two groups: one using standard MRI guidance and the other using CEST MRI. Individuals with a recent diagnosis of glioblastoma who have not yet received treatment might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a promising new surgical technique.

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.

What prior data suggests that this MRI technique is safe for glioblastoma patients?

Research has shown that CEST MRI is a promising tool in medicine, particularly for examining brain tumors. It can detect certain tumor features that standard MRI might miss.

Patients have generally tolerated this advanced imaging method well, with no major side effects specifically linked to CEST MRI, suggesting its safety for humans.

The trial's late phase indicates a high level of confidence in the procedure's safety, as it has passed earlier testing stages to ensure it doesn't cause harm. Overall, CEST MRI appears to be a safe imaging technique for patients, providing valuable information to help treat glioblastoma effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Chemical Exchange Saturation Transfer (CEST) MRI for glioblastoma because it offers a new way to guide surgical resections. Unlike standard MRI, which relies on contrast agents to highlight tumors, CEST MRI provides more detailed molecular information without additional contrast, potentially improving tumor visibility and precision during surgery. This could lead to more accurate removal of cancerous tissue while sparing healthy brain tissue, which is a significant advancement over the current standard of care. By enhancing the surgeon's ability to distinguish tumor margins, this technique aims to improve outcomes for patients battling this aggressive brain cancer.

What evidence suggests that CEST MRI is effective for glioblastoma?

Research has shown that a special type of MRI called Chemical Exchange Saturation Transfer (CEST) can help doctors better evaluate glioblastoma tumors. Studies have found that CEST MRI can identify tumor areas that regular MRIs might miss. This technique highlights differences in protein levels and cell acidity to create clearer images of the tumor. In this trial, participants in Group II will undergo surgical resection with intraoperative guidance using CEST MRI. In some cases, CEST MRI can detect changes in the tumor as early as two weeks into treatment. This early detection can help doctors decide if the current treatment is effective or needs adjustment. Overall, CEST MRI holds promise for better identifying and monitoring glioblastoma tumors. ^{2 6 7 8 9}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6033360/

Chemical exchange saturation transfer MRI serves as ... Recently, CEST MRI already showed the potential to enhance post-treatment response evaluation in glioblastoma [18, 30]. A pre-treatment ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301618306084

Evaluation of Glioblastoma Response to Therapy With ... Chemical exchange saturation transfer (CEST) provides imaging-based biomarkers of GBM response as early as 2 weeks into the treatment.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07121842

Glioblastoma Imaging for the Detection of Tumor ... In this study, the invesigators look at how a new MRI technique (called amide proton transfer weighted (APTw) chemical exchange saturation ...

4. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rycan.2020190036

Endogenous Chemical Exchange Saturation Transfer MRI ... Through this systematic review, we identified 36 research studies on the value of endogenous CEST techniques to depict brain tumor metabolism.

5. analyticalsciencejournals.onlinelibrary.wiley.com analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/nbm.5282

Saturation transfer (CEST and MT) MRI for characterization of ... Chemical exchange saturation transfer MRI serves as predictor of early progression in glioblastoma patients. Oncotarget. 2018; 9(47): 28772 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10557022/

Applications of chemical exchange saturation transfer MRI in ... We review its early applications in identifying IDH mutation status, MGMT methylation status, 1p/19q deletion status, and H3K27M mutation status in gliomas.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6828581/

Chemical exchange saturation transfer magnetic resonance ... With these promising results, CEST derived metrics have shown the possibility to characterize tumor aggressiveness and act as imaging biomarkers ...

8. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.040830

Chemical Exchange Saturation Transfer Magnetic ... We applied CEST magnetic resonance imaging to monitor molecular changes in hematoma without and with treatment noninvasively over 2 weeks at 3T using ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06448286?term=AREA%5BConditionSearch%5D(Glioblastoma)%20AND%20AREA%5BBasicSearch%5D(jonsson%20comprehensive)&rank=2

PH Weighted Chemical Exchange Saturation Transfer MRI ... This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to ...