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

Trial Summary

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 data supports the effectiveness of the treatment Intraoperative Electrocorticography for brain tumors?

Intraoperative Electrocorticography (ECoG) is used during brain tumor surgeries to help map brain functions and avoid damaging critical areas, which can improve the patient's quality of life and surgical outcomes. Studies suggest that using such monitoring techniques can help optimize tumor removal while preserving important brain functions. ^{1 2 3 4 5}

Is intraoperative brain activity monitoring safe for humans?

Intraoperative brain activity monitoring, like Electrocorticography (ECoG) and other similar techniques, is generally considered safe when used during brain surgeries. These methods help monitor brain function in real-time to reduce the risk of damage during surgery, and they are part of standard practices to improve patient safety. ^{6 7 8 9 10}

How is the standard surgical treatment for brain tumors unique compared to other treatments?

The standard surgical treatment for brain tumors is unique because it often involves intraoperative brain activity monitoring, which helps surgeons map and monitor neural pathways during the operation. This technique aims to preserve important brain functions and improve surgical outcomes by reducing the risk of neurological deficits. ^{2 4 11 12 13}

What is the purpose of this trial?

The purpose of this study is to test the safety and feasibility of recording brain activity within and around high-grade glioma tumors at the time of surgery. A small biopsy will be taken at the sites of the recordings.

Research Team

Jennifer Yu, MD, PhD

Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Surgical management of intracranial gliomas. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Awake craniotomy for brain tumor: indications, technique and benefits. [2014]

3. United States 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. [2022]

4. United States 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. [2018]

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

How Intraoperative Tools and Techniques Have Changed the Approach to Brain Tumor Surgery. [2019]

6. Austria 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. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Intra- and postoperative adverse events in awake craniotomy for intrinsic supratentorial brain tumors. [2021]

8. Japan pubmed.ncbi.nlm.nih.gov

[Perioperative management of skull base tumor surgery]. [2015]

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

Patterns in neurosurgical adverse events: intracranial neoplasm surgery. [2012]

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

Assessing brain stem function. [2005]

11. Italy pubmed.ncbi.nlm.nih.gov

Brain surgery in motor areas: the invaluable assistance of intraoperative neurophysiological monitoring. [2017]

12. Germany pubmed.ncbi.nlm.nih.gov

Image-Guided Brain Surgery. [2020]

13. Japan pubmed.ncbi.nlm.nih.gov

[Intraoperative Neuromonitoring for Skull Base Surgery]. [2022]