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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 42 days

Awards & highlights

Study Summary

This trial is looking at a new way to collect information from people with brain tumors during surgery, in order to learn more about the safety and feasibility of the new method, as well as to gather data about potential biomarkers for 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Targeted metabolomics

Secondary outcome measures

Microdialysate D-2HG

Necrotic core metabolites

Non-enhancing (FLAIR)- region metabolites

+1 more

Other outcome measures

Microdialysate oncometabolites

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 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,596 Total Patients Enrolled

322 Trials studying Glioblastoma

23,063 Patients Enrolled for Glioblastoma

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,808 Total Patients Enrolled

14 Trials studying Glioblastoma

747 Patients Enrolled for Glioblastoma

Terence C BurnsPrincipal InvestigatorMayo Clinic in Rochester

4 Previous Clinical Trials

379 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

Glioblastoma Research Study Groups: Basic Science (microdialysis)

Glioblastoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation accepted in this medical experiment?

"The terms of entry into this medical trial outline an age range for participants: a minimum of 18 and a maximum up to 89."

Answered by AI

Who qualifies to take part in this medical experiment?

"Eligibility for this research requires participants to have microdialysis and be between 18-89 years old. Approximately 52 individuals must sign up in order for the trial to proceed."

Answered by AI

Are there any vacancies open for participants in this clinical experiment?

"Affirmative. Clinicaltrials.gov provides evidence that the search for trial participants is still active, with an initial posting date of January 1st 2020 and a recent update on November 11th 2022. This medical experimentation requires 52 individuals from one location to be enlisted."

Answered by AI

How many participants have enrolled in this research project?

"Affirmative. Clinicaltrials.gov displays that this experiment is actively recruiting individuals, having been posted on the 1st of January 2020 and amended most recently on November 11th 2022. 52 patients are needed from just one medical centre to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

Terry Burns 2020. "Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04047264.

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