MRI-Guided Resection for Brain Tumor

Overseen By Kunal S Patel

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: VA Office of Research and Development

Disqualifiers: Extracranial malignancy, Autoimmune disease, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help doctors see and remove glioblastomas, a type of brain tumor. By using a special MRI that focuses on pH levels, surgeons aim to better identify and safely remove these hard-to-spot tumors. The study includes individuals newly diagnosed or with recurring glioblastoma with a specific type of brain mass, who can undergo surgery. All participants will receive this new MRI-based surgical approach to evaluate its effectiveness. 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.

What prior data suggests that this MRI-guided resection technique is safe for brain tumor patients?

Research has shown that using MRI during surgery can help doctors remove more of the glioblastoma tumor. This might increase the chances of removing the entire tumor and could help patients live longer. While this specific pH MRI technique is new, MRI-guided surgeries have been used before and are known to be safe.

In this study, safety remains a key focus. Doctors will monitor for any problems after the surgery, such as resection limiting toxicities (RLTs), which might affect recovery. MRI helps ensure the surgery remains as safe as possible.

This is a first-phase study, marking one of the first tests of this specific approach. The goal is to observe how the body responds to this new type of surgery. Although it's early, results from similar MRI-guided surgeries have shown positive safety outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided resection for brain tumors because it uses a novel approach to target glioblastoma multiforme (GBM). Unlike traditional surgical methods that rely on visual and tactile cues, this technique employs pH MRI to precisely differentiate between tumor tissue and healthy brain tissue. This precision could lead to more complete tumor removals while sparing healthy tissue, potentially improving outcomes and reducing side effects for patients.

What evidence suggests that this MRI-guided resection is effective for brain tumors?

Research has shown that using MRI during surgery can help remove more of the glioblastoma tumor, potentially increasing the chances of complete removal and extending a patient’s life. Studies suggest that MRI-based patterns of tumor spread may link to better survival outcomes. In this trial, all participants will receive the pH MRI-based resection, which specifically targets acidic areas of the tumor, often hard to see with standard imaging. This new method aims to improve visualization, helping surgeons safely remove more of the tumor. ^{1 2 3 6 7}

Who Is on the Research Team?

Kunal S Patel

Principal Investigator

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Are You a Good Fit for This Trial?

This trial is for individuals who can consent, have a performance status score of 70 or above, and are suspected to have or known to suffer from IDH wild type WHO IV glioblastoma without metastasis. It excludes those unfit for anesthesia/surgery and tumors in critical brain areas.

Inclusion Criteria

Ability to provide written informed consent

I am mostly able to care for myself.

I have a type of brain tumor known as glioblastoma without spread to other parts.

Exclusion Criteria

I cannot have surgery or anesthesia due to my health conditions.

My tumor affects critical brain areas involved in movement or speech.

I have a history of cancer outside the brain or an autoimmune disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants undergo standard medical clearance and a pre-operative MRI with pH-weighted amine CEST-EPI MRI scan

1 week

Surgery

Intraoperative CEST-EPI guided resections are performed to assess safety and remove infiltrative NE tumor

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety with follow-up MRIs at 24 hours, 2 weeks, and 4 weeks post-surgery

4 weeks

3 visits (in-person)

Adjuvant Therapy

Participants receive standard post-operative care and adjuvant therapy per established guidelines for glioblastoma

What Are the Treatments Tested in This Trial?

Interventions

• pH MRI based resection of GBM

Trial Overview The study tests a new MRI technique that measures pH levels to improve visualization of glioblastoma during surgery. The goal is to see if this method allows for safer removal of more tumor tissue in patients at the VA.

How Is the Trial Designed?

Group I: pH Resections Experimental Treatment 1 Intervention

This is a single arm study so all patients will receive the intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Citations

1. 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 ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10417432/

Advanced Magnetic Resonance Imaging in the Evaluation of ... Surgical resection aims to remove as much of the tumor as feasible without causing significant neurological deficits. Following surgery, RT is administered ...

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. academic.oup.com academic.oup.com/noa/advance-article/doi/10.1093/noajnl/vdaf114/8198193

MRI-defined patterns of infiltration and outcome in patients ... This paper strongly suggests a possible correlation of MRI-based infiltration patterns and survival in patients with glioblastoma by use of a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9143023/

Refining Glioblastoma Surgery through the Use of Intra ... Glioblastoma (GBM) is the most aggressive adult brain tumour with a dismal 2-year survival rate of 26–33%. Maximal safe resection plays a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949713223000952

Intraoperative glioblastoma surgery-current challenges and ... iMRI has emerged as a valuable tool in glioblastoma surgery, providing real-time imaging capabilities that enhance the accuracy and safety of tumor resection.