~30 spots leftby Sep 2027

Intraoperative Microdialysis for Brain Tumor

Recruiting in Palo Alto (17 mi)
+1 other location
TC
Overseen byTerence C Burns, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Pregnancy, Prisoners, Mental handicap, others
No Placebo Group
Approved in 2 Jurisdictions

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.12345

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.12678

Research Team

TC

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 am 18 years old or older.
I have a brain tumor that has spread from another part of my body.
I can take care of myself and perform daily activities.
See 5 more

Exclusion Criteria

Vulnerable populations: pregnant women, prisoners or the mentally handicapped
I cannot have surgery due to my health condition or another serious illness.

Trial 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 (Device)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Basic Science (microdialysis)Experimental Treatment2 Interventions
Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable profile image

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Jordan Gladman

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Medical Officer

MD from Harvard Medical School

Walter J. Koroshetz profile image

Walter J. Koroshetz

National Institute of Neurological Disorders and Stroke (NINDS)

Chief Executive Officer since 2007

MD from the University of Chicago

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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.
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]

References

A microdialysis technique for routine measurement of macromolecules in the injured human brain. [2019]
Intracerebral microdialysis in neurosurgical intensive care patients utilising catheters with different molecular cut-off (20 and 100 kD). [2019]
Technical notes on the placement of cerebral microdialysis: A single center experience. [2023]
Monitoring of brain metabolism during aneurysm surgery using microdialysis and brain multiparameter sensors. [2022]
Intraoperative on-line monitoring of cerebral pH by microdialysis in neurosurgical procedures. [2019]
Review of microdialysis in brain tumors, from concept to application: first annual Carolyn Frye-Halloran symposium. [2018]
Cerebral microdialysis: research technique or clinical tool. [2018]
Intra-operative, real-time, three-dimensional ultrasound assisted positioning of catheters in the microdialysis of glial tumours. [2010]