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

Trial Summary

What is the purpose of this trial?

This trial uses a small device during brain surgery to collect fluid samples from patients with brain tumors. The collected fluid is tested to find indicators of the disease. This information may help doctors better diagnose, monitor, and treat brain tumors.

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.

Is intraoperative microdialysis for brain tumor surgery safe?

Intraoperative microdialysis has been used in various neurosurgical procedures to monitor brain metabolism and pH levels, with some patients experiencing stable outcomes and others having complications like hemiparesis (weakness on one side of the body). While it shows potential for monitoring, more experience is needed to fully understand its safety. ^{1 2 3 4 5}

How is intraoperative cerebral microdialysis different from other treatments for brain tumors?

Intraoperative cerebral microdialysis is unique because it allows real-time sampling of the fluid around brain tumors during surgery, providing direct information about the tumor environment and drug levels, unlike traditional methods that rely on blood or spinal fluid samples. This technique uses a special catheter to collect molecules directly from the tumor area, offering more precise data for treatment decisions. ^{1 2 6 7 8}

Research Team

Terence C Burns, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

Vulnerable populations: pregnant women, prisoners or the mentally handicapped

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

A microdialysis technique for routine measurement of macromolecules in the injured human brain. [2019]

2. Austria pubmed.ncbi.nlm.nih.gov

Intracerebral microdialysis in neurosurgical intensive care patients utilising catheters with different molecular cut-off (20 and 100 kD). [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Technical notes on the placement of cerebral microdialysis: A single center experience. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Monitoring of brain metabolism during aneurysm surgery using microdialysis and brain multiparameter sensors. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Intraoperative on-line monitoring of cerebral pH by microdialysis in neurosurgical procedures. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Review of microdialysis in brain tumors, from concept to application: first annual Carolyn Frye-Halloran symposium. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Cerebral microdialysis: research technique or clinical tool. [2018]

8. Scotland pubmed.ncbi.nlm.nih.gov

Intra-operative, real-time, three-dimensional ultrasound assisted positioning of catheters in the microdialysis of glial tumours. [2010]