MRI-Guided Surgery for Glioblastoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Los Angeles

Disqualifiers: Pediatric, Anesthesia risk, Eloquent areas, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new MRI technique to guide surgery for glioblastoma, an aggressive brain cancer. Researchers hope this method, called CEST PH MRI-based resection, will safely remove more cancerous tissue and potentially improve survival rates. Suitable participants are those diagnosed with glioblastoma without involvement in critical brain areas, such as those controlling movement or speech. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer based on your specific situation.

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

Earlier studies have tested a special type of MRI called pH-sensitive MRI, using the CEST-EPI technique, to guide surgeries for glioblastoma, a type of brain tumor. Initial results suggest this method helps doctors find and remove more tumor tissue, which regular MRI scans often miss.

Previous research examined the safety of this approach by checking for complications after surgery, known as resection limiting toxicities (RLTs). Patients received close monitoring after their surgeries and follow-up MRI scans to ensure no serious side effects occurred.

Since this is an early phase study, researchers are still learning about the treatment's safety. However, similar methods have been used before without major safety issues, suggesting it might be safe. The study is designed to monitor participants carefully to quickly identify any potential risks, aiming to remove as much of the tumor as safely possible. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided surgery for glioblastoma because it uses an innovative imaging technique called CEST PH MRI to guide tumor resection. Unlike standard surgeries that rely on traditional imaging and may not capture all tumor tissue, this method provides real-time, precise mapping of the tumor, potentially allowing surgeons to remove more of the cancerous cells while sparing healthy tissue. This could lead to improved outcomes when combined with standard post-surgical treatments like temozolomide and radiation therapy. This approach promises to enhance surgical accuracy and effectiveness in treating glioblastoma, a notoriously aggressive brain tumor.

What evidence suggests that this MRI-guided surgery is effective for glioblastoma?

Research has shown that using MRI scans during surgery can help doctors remove more of the glioblastoma tumor, potentially increasing the chances of complete removal. This trial studies the pH-sensitive CEST MRI technique for its ability to reveal tumor parts that regular MRIs might miss. This technique could help identify and remove more tumor tissue, especially in hard-to-see areas. Studies suggest that this method could help patients remain disease-free longer and improve overall survival. While promising, information about its effectiveness in humans is still being collected. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with newly diagnosed glioblastoma, a type of brain cancer. Participants must be eligible for standard care and FDA approved therapies. The study aims to include those who can potentially benefit from an advanced MRI technique during surgery.

Inclusion Criteria

I have been recently diagnosed with glioblastoma.

I am 18 years old or older.

Exclusion Criteria

Direct involvement of eloquent language or motor areas

I cannot undergo surgery for my glioblastoma.

I have had cancer treatment like chemo, radiation, or targeted therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Standard pre-operative medical clearance and MRI including gadolinium contrast and CEST-EPI

1 day

1 visit (in-person)

Surgery

Intraoperative CEST-EPI guided resection of glioblastoma with biopsy and comparison using 5-ALA

1 day

1 visit (in-person)

Post-operative Follow-up

Immediate post-operative MRI and monitoring for surgical complications

1-3 days inpatient, 4 weeks outpatient

1-3 days inpatient, 2 visits (outpatient)

Standard of Care Follow-up

Standard of care follow-up with MRI and clinical assessment starting at 8 weeks

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• CEST PH MRI based resection of glioblastoma

Trial Overview The trial tests whether using a pH-sensitive MRI method called CEST during surgery to remove glioblastoma improves survival rates. Patients are randomly chosen to either have this new technique or the standard treatment, comparing their progression-free and overall survival.

How Is the Trial Designed?

Group I: CEST Resection Experimental Treatment 1 Intervention

CEST MRI Based Resection of glioblastoma with standard of care adjuvant therpay (temozolomide + radiation therapy)

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

In a study of 42 patients undergoing awake surgery for gliomas over 5 years, the overall complication rate was 59%, with 36% experiencing transient neurological deficits and 26% facing permanent deficits, indicating a significant risk of adverse events during this procedure.

Despite the high complication rate, the functional outcomes were promising, with all patients achieving a Karnofsky Performance Score of 80 or higher at 3-month follow-up, suggesting that awake surgery can be effective in preserving function while treating gliomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized reporting of adverse events and functional status from the first 5 years of awake surgery for gliomas: a population-based single-institution consecutive series. Jensdottir, M., Beniaminov, S., Jakola, AS., et al.[2022]

Citations

1. 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 ... PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11695364/

Multipool-CEST and CEST-based pH assessment as ... CEST-based tumor pH assessment and metabolic profiling demonstrated promising potential for predicting glioma grade, IDH mutation status, 1p/19q codeletion, ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2024-01961

PH Weighted Chemical Exchange Saturation Transfer MRI ... PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.

4. withpower.com withpower.com/trial/phase-glioblastoma-2024-a7012

MRI-Guided Surgery for Glioblastoma Research shows that using MRI during surgery helps remove more of the glioblastoma tumor, increasing the chances of complete removal and potentially extending ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07218367

NCT07218367 | Phase I Trial of pH Resections of GBM at VA This is a single center, single arm, phase 1 surgical dose escalation clinical trial with a preliminary efficacy study at the recommended safe ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06176066

PH Sensitive MRI Based Resections of Glioblastoma The primary endpoint for this study will be safety of resecting "CEST positive", acidic regions within T2 hyperintense regions of glioblastoma thought to ...

7. isrctn.com isrctn.com/pdf/86522205

Imaging glioblastoma pH using CEST-MRI The main aim of this study is to evaluate images obtained from CEST MRI in patients with glioblastoma, a type of brain cancer. The CEST-MRI data will also be ...