Intraoperative Brain Activity Monitoring for Brain Tumor

Overseen By Jennifer Yu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Severe comorbidity, Major illnesses, Pregnancy, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the safety and feasibility of monitoring brain activity during surgery for individuals with high-grade gliomas, an aggressive type of brain tumor. During surgery, doctors will use Intraoperative Electrocorticography (ECoG) to record brain activity and collect a small tissue sample to learn more about these tumors. The trial seeks participants with a confirmed high-grade glioma diagnosis or those undergoing surgery for a suspected recurrence of this condition. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking medical knowledge.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that intraoperative electrocorticography is safe for brain tumor surgery?

Studies have shown that intraoperative electrocorticography (ECoG) during brain surgeries is generally safe and helpful. ECoG records brain activity directly from the brain's surface. Research suggests it is well-tolerated in assisting surgeries, especially for epilepsy. Patients who underwent this procedure did not report significant additional risks compared to standard surgery alone.

In this trial, ECoG will accompany regular surgical treatment for brain tumors. Although this trial is in its early stages and safety information is still being collected, previous research on ECoG in other surgeries provides some reassurance about its potential safety. Since the FDA has approved the technology used in ECoG, it has already met certain safety standards. However, as with any surgery, risks can occur, so discussing these with doctors is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of intraoperative electrocorticography (ECOG) for brain tumor surgeries because it offers a unique way to monitor brain activity in real-time during surgery. Unlike standard surgical treatments that rely solely on imaging and preoperative planning, ECOG involves placing electrodes directly on the brain's surface to record electrical activity. This method can provide immediate feedback to surgeons, helping them to better understand the relationship between brain function and tumor location. By doing so, it may enhance the precision of tumor removal and potentially preserve important neurological functions, which is a significant advancement over current approaches.

What evidence suggests that intraoperative electrocorticography is effective for brain tumor surgery?

Research has shown that using intraoperative electrocorticography (ECoG) during surgery can improve outcomes, particularly for epilepsy related to brain tumors. Studies have demonstrated that ECoG helps identify brain areas causing seizures, leading to better surgical results. Specifically, one study found that about 74% of patients experienced positive outcomes after surgery with ECoG. Although this data primarily focuses on epilepsy, the technique's ability to locate problem areas suggests it could also benefit brain tumor surgeries. In this trial, participants will receive standard surgical treatment combined with ECoG, which provides real-time information about brain activity during surgery, aiding doctors in making precise decisions. ^{1 3 6 7 8}

Who Is on the Research Team?

Jennifer Yu, MD, PhD

Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with high-grade gliomas visible on MRI, who've had a confirmed diagnosis and are undergoing surgery for recurrent tumors. They must be in good enough health to have surgery, not pregnant, without severe bleeding risks or major illnesses that could interfere with the study.

Inclusion Criteria

Appearance of high-grade glioma on magnetic resonance imaging

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial

My recent lab tests show I'm fit for brain surgery.

Exclusion Criteria

Pregnancy

I have a bleeding disorder that could make surgery risky.

Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Intraoperative Recording

Participants undergo intraoperative electrocorticography and tissue biopsy during standard surgical treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with follow-up MRIs to assess tumor progression

9 months

Multiple visits (in-person) for MRI

Study Completion

Final assessments and bioinformatics analyses are performed to correlate electrical activity with molecular profiles

1 year post treatment

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Electrocorticography
• Standard Surgical Treatment

Trial Overview

The study is testing the safety of recording brain activity from high-grade glioma tumors during surgery. Participants will receive standard surgical treatment along with intraoperative electrocorticography where brain activity is recorded and a small biopsy taken.

How Is the Trial Designed?

Group I: Standard Surgical Treatment + Intraoperative Electrocorticography Experimental Treatment 2 Interventions

Each participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology. During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.

Standard Surgical Treatment is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Standard Surgical Treatment for:

• High-grade glioma
• Brain tumors
• Neurosurgical procedures

Approved in United States as Standard Surgical Treatment for:

• High-grade glioma
• Brain tumors
• Neurosurgical procedures

Approved in Canada as Standard Surgical Treatment for:

• High-grade glioma
• Brain tumors
• Neurosurgical procedures

Approved in Japan as Standard Surgical Treatment for:

• High-grade glioma
• Brain tumors
• Neurosurgical procedures

Approved in China as Standard Surgical Treatment for:

• High-grade glioma
• Brain tumors
• Neurosurgical procedures

Approved in Switzerland as Standard Surgical Treatment for:

• High-grade glioma
• Brain tumors
• Neurosurgical procedures

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Burkhardt Brain Tumor and Neuro-Oncology Center

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

The review of cranial tumor surgeries revealed that complication rates can range from 9% to 40%, with deep venous thromboembolism (DVT) being the most common adverse event, occurring in 3% to 26% of cases.

Implementing standardized safety protocols, such as DVT prophylaxis and intraoperative navigation techniques, could potentially reduce the incidence of adverse events and improve patient outcomes in neurosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns in neurosurgical adverse events: intracranial neoplasm surgery. Wong, JM., Panchmatia, JR., Ziewacz, JE., et al.[2012]

In a study of 140 patients undergoing glioma resection, the use of intermittent general anesthesia with controlled ventilation was found to be feasible and relatively safe, with only one case of aspiration and no mortality reported.

The awake phases allowed for effective mapping of brain functions, with patients remaining awake for an average of 98 minutes, which can enhance surgical outcomes while preserving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent general anesthesia with controlled ventilation for asleep-awake-asleep brain surgery: a prospective series of 140 gliomas in eloquent areas. Deras, P., Moulinié, G., Maldonado, IL., et al.[2022]

Recent advancements in surgical techniques and perioperative management for skull base tumor surgery have expanded the range of complex procedures that can be safely performed, increasing the anesthesiologist's role in patient care.

Intraoperative electrophysiological monitoring (IOEM) is crucial for protecting neurons during surgery, as it helps prevent damage from surgical maneuvers, and anesthesiologists must stay updated on effective methods to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perioperative management of skull base tumor surgery]. Minemura, H., Kawamata, M.[2015]

Intraoperative neuromonitoring techniques, such as motor evoked potentials (MEP) and brainstem auditory evoked potentials (BAEP), are crucial for evaluating and preserving neural functions during skull base tumor surgeries.

These techniques help prevent irreversible damage to cranial nerves and reduce the risk of postoperative neurological deficits, ultimately improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intraoperative Neuromonitoring for Skull Base Surgery]. Oishi, M., Fujii, Y.[2022]

In a study of 25 patients undergoing awake craniotomy for brain tumors, 92% experienced surgery-related inconveniences, with intraoperative hypertension being the most common issue (32%).

Postoperatively, 68% of patients faced adverse events, primarily new language deficits (40%) and motor deficits (36%), highlighting significant risks associated with this surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra- and postoperative adverse events in awake craniotomy for intrinsic supratentorial brain tumors. Kwinta, BM., Myszka, AM., Bigaj, MM., et al.[2021]

Intraoperative imaging techniques, including neuronavigation and fluorescence-guided surgery, are crucial for improving the accuracy of tumor resection in malignant gliomas, which are difficult to distinguish from normal brain tissue.

Advanced methods like targeted fluorescence spectroscopy and Raman spectroscopy offer highly precise imaging options that enhance tumor visualization during surgery, potentially leading to better surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-Guided Brain Surgery. Schipmann-Miletić, S., Stummer, W.[2020]

In a study of 856 glioma patients, those who underwent intraoperative neurophysiologic monitoring (IONM) had significantly longer overall survival compared to those who did not receive IONM, particularly in patients with high-grade astrocytic tumors.

Patients in the IONM group also experienced fewer late neurologic deficits, indicating that IONM not only improves survival outcomes but also enhances long-term neurological function after tumor resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Functional and Oncologic Outcomes of Glioma Surgery with and without Intraoperative Neurophysiologic Monitoring: A Retrospective Cohort Study in a Single Center. Zhang, N., Yu, Z., Hameed, NUF., et al.[2018]

Awake craniotomy for brain tumor surgery allows for real-time brain mapping, which helps assess and preserve critical areas of the brain, reducing the risk of neurological deficits and improving patients' quality of life post-surgery.

This method not only enhances the medical outcomes of brain tumor treatment but also presents favorable economic benefits, making it a valuable approach in neurosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awake craniotomy for brain tumor: indications, technique and benefits. Dziedzic, T., Bernstein, M.[2014]

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]

Recent technological advancements, such as intraoperative MRI and fluorescent dyes, have significantly improved the extent of surgical resection for brain tumors, allowing surgeons to remove more tumor tissue safely.

Neurophysiological monitoring during surgery has reduced the risk of neurological injury, while new operative scopes and laser interstitial therapy have expanded treatment options for previously inoperable brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Intraoperative Tools and Techniques Have Changed the Approach to Brain Tumor Surgery. Fatemi, P., Zhang, M., Miller, KJ., et al.[2019]

Intraoperative neurophysiological monitoring (INM) during brain tumor surgeries significantly enhances the safety and effectiveness of the procedure by providing continuous assessment of motor pathway integrity, allowing for early detection of potential injuries.

In a study of 51 patients, the use of monitoring techniques resulted in a high success rate for recording motor evoked potentials (98%) and effectively prevented irreversible motor system injuries, with 66% of patients maintaining their preoperative status after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain surgery in motor areas: the invaluable assistance of intraoperative neurophysiological monitoring. Sala, F., Lanteri, P.[2017]

Intraoperative neurophysiologic monitoring offers real-time, objective assessments of nervous system function, which is crucial when performing surgeries near the brain stem.

These monitoring techniques help correlate surgical actions with brain stem function, significantly reducing the risk of damaging critical areas during operations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing brain stem function. Sclabassi, RJ., Kalia, KK., Sekhar, L., et al.[2005]

Surgery is crucial for glioma patients, as it helps obtain tissue diagnoses, relieve symptoms, and potentially improve survival by reducing tumor size, with maximal safe surgical removal being beneficial for most glioma types.

Modern techniques like stereotactic biopsies and advanced imaging technologies are enhancing surgical outcomes and reducing risks, although the long-term benefits of these methods still need further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical management of intracranial gliomas. Simon, M., Schramm, J.[2015]

Citations

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pmc.ncbi.nlm.nih.gov

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Intraoperative electrocorticography in focal drug-resistant ...

The present study provides evidence supporting the effectiveness of intraoperative ECoG in improving surgical outcomes for patients with DRE.

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sciencedirect.com

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The utility of intraoperative ECoG in tumor-related epilepsy

Intraoperative ECoG is generally considered a useful technique in delineating epileptogenic areas and improving the prognosis of surgical treatment of tumor- ...

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Seizure Outcome After Intraoperative Electrocorticography ...

Although limited by low-quality evidence, our meta-analysis shows a relatively good surgical outcome (74% FSO) after epilepsy surgery with ...

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We conducted retrospective analysis of the ECoG data of 16 patients, who underwent awake craniotomies because of left-sided brain tumours at our ...

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frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.625474/full

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The purpose of this study was to implement novel scale-free measures to assess how cortical physiology is altered by the presence of an invasive brain tumor.

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Intraoperative electrocorticography in epilepsy surgery

ECoG eminently aids removal of developmental malformations of brain, and most importantly, the excision of highly epileptogenic cortical dysplasias (CDs) for ...

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Overall, 73.3% of patients (11/15) showed positive intraoperative ECoG, with better outcomes in group II (85.7% Engel class IA) than in group I ...

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ACNS Guideline Minimum Technical Requirements for ...

High frequency oscillations have been used in the context of intraoperative ECoG and will be discussed below in section 4.3 and 4.4 (Frauscher et al., 2017).