What side effects are associated with this type of intervention?

Common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy. Surgery can lead to complications such as infection, bleeding, and neurological deficits. Radiation therapy often results in fatigue, hair loss, and skin changes, and can also cause long-term cognitive decline. Chemotherapy, particularly with agents like temozolomide, can cause nausea, vomiting, fatigue, and increased risk of infections due to bone marrow suppression. Treatments involving biomarker collection during neurosurgery, such as the use of microdialysis catheters, may add risks related to the surgical procedure itself, including infection and potential damage to surrounding brain tissue.

What prior FDA approvals exist?

The FDA has approved several treatments for Glioblastoma, including temozolomide, which is an oral alkylating agent used in combination with radiation therapy and as maintenance therapy. Bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF), has also been approved for recurrent Glioblastoma. These treatments focus on targeting tumor growth and proliferation, similar to the investigational approaches involving biomarker collection through microdialysis catheters, which aim to better diagnose, monitor, and treat brain tumors.

What other types of research exist?

Promising alternatives to microdialysis catheters for glioblastoma patients in 2024 include liquid biopsy techniques (such as circulating tumor DNA and RNA analysis), advanced imaging methods (like MRI with advanced contrast agents), and novel biosensor technologies that can detect biomarkers in bodily fluids non-invasively.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 days

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

0 / 7Eligibility criteria met

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.