Intraoperative Microdialysis for Brain Tumor

Recruiting at 1 trial location

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Prisoners, Mental handicap, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the use of microdialysis during brain surgery to collect biomarkers, which are measurable indicators of disease presence or severity. The researchers seek to determine if this approach can improve diagnosis and treatment strategies for brain tumors. Participants should have a glioma, a metastatic brain tumor, or an epileptic focus requiring surgical removal. Those undergoing neurosurgery at Mayo Clinic in Rochester, Minnesota, might find this study suitable. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future brain tumor treatments.

Do I need to stop my current medications for the trial?

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 intraoperative cerebral microdialysis is safe for brain tumor surgery?

Research has shown that using a microdialysis catheter during brain surgery is safe and well-tolerated. In a past study, this tool was successfully used in 10 patients in a coma, collecting important molecules from the brain without causing harm. The catheter is minimally invasive, entering the brain tissue only slightly, which reduces the risk of major side effects.

Additionally, microdialysis has been used to study drug movement through the brain and to gather biomarkers, measurable signs of disease. This process is efficient and has proven effective in live human brain studies. The safety record from these past uses suggests that the procedure is generally well-tolerated, making it a promising option for those considering trials involving brain tumor surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intraoperative cerebral microdialysis technique for brain tumors because it offers a new way to monitor the chemical environment of the brain in real-time during surgery. Unlike traditional methods that may rely on post-surgical analysis, this approach uses a microdialysis pump and catheter to provide immediate feedback on the biochemical changes occurring in the brain tissue. This real-time monitoring can potentially lead to more precise surgical interventions and a better understanding of tumor behavior, ultimately improving patient outcomes.

What evidence suggests that intraoperative cerebral microdialysis is effective for brain tumors?

Research has shown that intraoperative cerebral microdialysis, a technique participants in this trial will undergo, can be helpful during brain surgery. This method allows doctors to take samples from the brain during the procedure, gathering important information about disease severity or presence. It has been used to monitor brain metabolism, aiding doctors in understanding brain health. The specially designed microdialysis catheter is minimally invasive, causing less disruption to brain tissue. Although still under study, this method shows promise for better diagnosing and treating brain tumors by providing real-time information during surgery. ^{1 3 4 5 6}

Who Is on the Research Team?

Terence C Burns, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Adults (18+) with certain brain tumors or epilepsy needing surgery can join. They should be in fair to good health otherwise, as measured by ECOG performance status. Surgery must be planned at Mayo Clinic in Rochester, MN, and participants need to consent to the study.

Inclusion Criteria

I have a brain tumor that has spread from another part of my body.

I can take care of myself and perform daily activities.

I have been diagnosed with a type of brain tumor known as diffuse glioma.

Exclusion Criteria

I cannot have surgery due to my health condition or another serious illness.

Vulnerable populations: pregnant women, prisoners or the mentally handicapped

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Microdialysis

Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter

Trial Overview The trial is testing if microdialysis catheters can be used during neurosurgery to collect biomarkers from brain tissue. This could help doctors better understand and treat central nervous system malignancies.

How Is the Trial Designed?

Group I: Basic Science (microdialysis) Experimental Treatment 2 Interventions

Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.

Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter is already approved in United States, European Union for the following indications:

Approved in United States as Intraoperative cerebral microdialysis for:

• Central nervous system malignancies

Approved in European Union as Intraoperative cerebral microdialysis for:

• Traumatic brain injury
• Aneurysmal subarachnoid hemorrhage
• Central nervous system malignancies

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 10 microdialysis catheters and 15 multiparameter sensors, short periods of temporary clipping during aneurysm surgery (less than 3 minutes) were well tolerated, showing no significant changes in brain oxygen levels or lactate/pyruvate ratios, indicating stable brain metabolism.

However, prolonged temporary clipping led to metabolic disturbances, highlighting the importance of monitoring brain metabolism during surgery to prevent adverse effects in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring of brain metabolism during aneurysm surgery using microdialysis and brain multiparameter sensors. Hutchinson, PJ., Al-Rawi, PG., O'Connell, MT., et al.[2022]

A new intracerebral microdialysis catheter with a high-cutoff membrane was successfully used in 10 comatose patients, allowing for the sampling of macromolecules like interleukin-6, which reached concentrations as high as 25,000 pg/ml.

The study demonstrated that using Ringer-dextran 60 as a perfusion fluid improved the recovery of metabolites compared to standard fluids, indicating that this catheter can enhance the analysis of brain conditions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microdialysis technique for routine measurement of macromolecules in the injured human brain. Hillman, J., Aneman, O., Anderson, C., et al.[2019]

On-line monitoring of cerebral pH using microdialysis during complex neurosurgical procedures can help detect cerebrovascular complications, such as impending ischemia, in real-time.

In a study of 17 patients undergoing various neurosurgeries, changes in pH levels correlated with patient outcomes, indicating that pH monitoring could be a valuable tool for improving surgical safety, although more experience is needed before widespread adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative on-line monitoring of cerebral pH by microdialysis in neurosurgical procedures. Mendelowitsch, A., Sekhar, LN., Caputy, AJ., et al.[2019]

Cerebral microdialysis is a valuable tool for monitoring brain biochemistry in real-time during neurointensive care, helping to assess acute brain injury.

While it shows promise for becoming a standard part of monitoring in acute brain injury management, it is currently recommended for use primarily in research settings at specialized centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral microdialysis: research technique or clinical tool. Tisdall, MM., Smith, M.[2018]

Microdialysis is a promising technique for monitoring drug delivery and metabolism directly within brain tumors and surrounding tissue, offering a more accurate assessment than traditional serum or cerebrospinal fluid analyses.

This review supports the use of microdialysis in clinical trials for brain tumor therapies, as it can provide critical data on drug concentrations in the tumor environment, which is essential for optimizing treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of microdialysis in brain tumors, from concept to application: first annual Carolyn Frye-Halloran symposium. Benjamin, RK., Hochberg, FH., Fox, E., et al.[2018]

The new high cut-off micro-dialysis catheter (D(100)) allows for the recovery of significantly more protein compared to the standard CMA70 catheter, indicating its potential for better sampling of larger molecules in the brain's extracellular space.

While both catheters showed similar fluid recovery rates, the D(100) catheter had lower lactate recovery, which could affect the interpretation of metabolic states in comatose patients, suggesting careful consideration in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracerebral microdialysis in neurosurgical intensive care patients utilising catheters with different molecular cut-off (20 and 100 kD). Hillman, J., Milos, P., Yu, ZQ., et al.[2019]

Intra-operative three-dimensional ultrasonography (3D-US) was successfully used to accurately position microdialysis catheters in seven patients with high-grade astrocytoma, ensuring they were placed in viable tumor tissue.

The technique allowed for real-time adjustments to catheter placement, which was validated by pathological examination and confirmed the quality of the collected microdialysate using advanced chromatography methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-operative, real-time, three-dimensional ultrasound assisted positioning of catheters in the microdialysis of glial tumours. Homapour, B., Bowen, JE., Want, EJ., et al.[2010]

Cerebral microdialysis is a valuable tool for monitoring brain metabolism in patients with brain injuries, with 82 catheters successfully used in 52 patients over a 4-year period.

The study found no significant differences in catheter placement success or complications between using a quad-lumen bolt and craniotomy, indicating flexibility in choosing placement methods for optimal brain monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical notes on the placement of cerebral microdialysis: A single center experience. Falcone, JA., Chen, JW.[2023]

Citations

1. withpower.com withpower.com/trial/phase-neoplasms-2020-ceac8

Intraoperative Microdialysis for Brain Tumor A new intracerebral microdialysis catheter with a high-cutoff membrane was successfully used in 10 comatose patients, allowing for the sampling of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10729367/

Methodological and analytical considerations for intra ... Intra-operative HMW microdialysis can feasibly be utilized to sample the live human CNS microenvironment, including both metabolites and drugs, within one ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1085540/full

An overview of clinical cerebral microdialysis in acute brain ... Cerebral microdialysis is an invasive monitoring technique used in neurocritical care (Figure 1A) that allows continuous monitoring of cerebral metabolism.

4. mdialysis.com mdialysis.com/product/71-high-cut-off-brain-microdialysis-catheter/

71 High Cut-Off Brain Microdialysis Catheter The sterile, single use 71 High Cut-Off Brain Microdialysis Catheter is minimally invasive and designed for implantation in brain tissue.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04047264

NCT04047264 | Feasibility of Intraoperative Microdialysis ... This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intraoperative ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04047264?tab=history&a=1

Record History | ver. 1: 2019-08-05 | NCT04047264 Microdialysis permits sampling of molecules from the extracellular fluid, and has been utilized for studies of pharmacokinetics, and recovery of biomarkers.