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Device

Intraoperative Microdialysis for Brain Tumor

N/A
Recruiting
Led By Terence C Burns
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Diagnosis of a metastatic brain tumor of any primary origin based on clinical and radiographic evidence
Must not have
Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 days
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves standard surgical procedures with an additional step of microdialysis, potential side effects may include typical surgical risks such as infection, bleeding, or reactions related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have a brain tumor that has spread from another part of my body.
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I can take care of myself and perform daily activities.
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I have been diagnosed with a type of brain tumor known as diffuse glioma.
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I am willing to have brain surgery or a biopsy at Mayo Clinic in Rochester, MN.
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I need surgery for epilepsy based on tests and symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have surgery due to my health condition or another serious illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Targeted metabolomics
Secondary study objectives
Microdialysate D-2HG
Necrotic core metabolites
Non-enhancing (FLAIR)- region metabolites
+1 more
Other study objectives
Microdialysate oncometabolites

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Basic Science (microdialysis)Experimental Treatment1 Intervention
Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Microdialysis
2013
Completed Early Phase 1
~350

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy. Surgery aims to remove as much of the tumor as possible, which can alleviate symptoms and enhance the effectiveness of subsequent treatments. Radiation therapy uses high-energy beams to kill cancer cells and shrink tumors. Chemotherapy, particularly with temozolomide, damages the DNA of cancer cells, preventing them from dividing and growing. The collection of biomarkers through microdialysis catheters during surgery can provide real-time data on the tumor's biochemical environment, potentially leading to more personalized and effective treatment strategies. This matters for Glioblastoma patients as it can improve treatment outcomes and quality of life.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,376 Previous Clinical Trials
651,433 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,401 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,120 Total Patients Enrolled

Media Library

Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04047264 — N/A
Brain Tumor Research Study Groups: Basic Science (microdialysis)
Brain Tumor Clinical Trial 2023: Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter Highlights & Side Effects. Trial Name: NCT04047264 — N/A
Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04047264 — N/A
~19 spots leftby Sep 2027