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Procedure
Focused Ultrasound for Brain Tumor
N/A
Recruiting
Led By Terence C. Burns, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post-surgery
Awards & highlights
Study Summary
This trial looks at how focused ultrasound (FUS) affects tumor microenvironments. Researchers will compare areas with and without FUS to measure changes in the brain & tumor molecules. It could lead to new ways to study cancer drugs & therapies.
Who is the study for?
This trial is for adults with a suspected or diagnosed diffuse glioma brain tumor, large enough (≥3cm) to be partially targeted by focused ultrasound but small enough for standard surgery. Participants must be able to undergo surgery in Rochester, MN and have an ECOG performance status of 0-2. Pregnant women, prisoners, those mentally handicapped, or anyone with certain cardiac diseases or blood-borne infections are excluded.Check my eligibility
What is being tested?
The study tests the effect of focused ultrasound on brain tumors using InSightec's ExAblate Neuro Model system. It aims to understand how this technique alters the tumor microenvironment by comparing regions treated with FUS against untreated ones through microdialysis catheters.See study design
What are the potential side effects?
Potential side effects may include risks associated with general surgical procedures such as infection and bleeding. Specific side effects related to the use of focused ultrasound and disruption of the blood-brain barrier are not detailed but could involve neurological changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Number of microdialysate aliquots
Trial Design
1Treatment groups
Experimental Treatment
Group I: Focused UltrasoundExperimental Treatment1 Intervention
Subjects with known or suspected glioma (≥3cm) undergoing routine planned neurosurgical resection will undergo a focused ultrasound prior to the surgery with the InSightec's ExAblate Neuro Model 4000 Type 2.0 (220 KHz) system
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,211 Previous Clinical Trials
3,766,992 Total Patients Enrolled
Terence C. Burns, M.D., Ph.D.Principal InvestigatorMayo Clinic
3 Previous Clinical Trials
339 Total Patients Enrolled
Terence Burns, MDPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for brain surgery to remove a tumor.I have seizures not caused by my tumor, or a drug/alcohol problem, not controlled by medication.I cannot use Definity® due to health reasons.I do not have infections that could cause brain problems due to a weakened blood-brain barrier.My skull shape may increase risks in focused ultrasound surgery.I have a brain tumor that is the right size for focused ultrasound but can still be partially removed surgically.I can care for myself and am up and about more than 50% of my waking hours.I do not have heart or blood clotting conditions that would prevent certain treatments.My surgeon does not require 5-ALA for my surgery.I am willing to have brain surgery at Mayo Clinic in Rochester, MN.
Research Study Groups:
This trial has the following groups:- Group 1: Focused Ultrasound
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What has been the total enrollment in this research endeavor?
"Affirmative. Per the information listed on clinicaltrials.gov, this research is recruiting participants as of February 8th 2023 and was first posted March 1st 2023 with a target recruitment size of 6 people at one location."
Answered by AI
Are fresh recruits being accepted for this trial at present?
"Affirmative. According to the ClinicalTrials.gov website, this medical trial was posted on March 1st 2023 and has most recently been updated on February 8th 2023. The study is searching for a total of 6 participants across one center."
Answered by AI
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