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Procedure

ExAblate 4000 System for Brain Tumor

N/A

Recruiting

Led By John Ragheb, MD

Research Sponsored by InSightec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 12 month follow up

Awards & highlights

Study Summary

This trial is to study if a new treatment for brain tumors is safe and feasible in children and young adults.

Who is the study for?

This study is for children and young adults with non-cancerous brain tumors that need treatment, can fit in an MRI machine, and have a head circumference of at least 52cm. They should be stable on current medications for their condition. Those with malignant tumors, unclear diagnosis without biopsy, or unable to undergo anesthesia are excluded.Check my eligibility

What is being tested?

The trial is testing the ExAblate 4000 System's safety and feasibility in treating benign brain tumors by using focused ultrasound waves to heat and destroy tumor tissue without invasive surgery.See study design

What are the potential side effects?

While specific side effects aren't listed here, similar procedures may include risks like headache, discomfort at the treatment site, nausea, or dizziness. There could also be unique risks associated with using this device in pediatric patients.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 12 month follow up 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 Treatment-Emergent Adverse Events Safety and Tolerability

Measurement of Tumor Volume

Secondary outcome measures

Changes in the General Physical Exam

Changes in the Neurological Exam

Confrontational Visual Field Testing

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ExAblate 4000 SystemExperimental Treatment1 Intervention

MR-Guided Focused Ultrasound

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor

89 Previous Clinical Trials

3,704 Total Patients Enrolled

John Ragheb, MDPrincipal InvestigatorMiami Children's Research Institute - Nicklaus Children's Hospital

Media Library

ExAblate 4000 System (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03028246 — N/A

Benign CNS Tumors Research Study Groups: ExAblate 4000 System

Benign CNS Tumors Clinical Trial 2023: ExAblate 4000 System Highlights & Side Effects. Trial Name: NCT03028246 — N/A

ExAblate 4000 System (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03028246 — N/A

Frequently Asked Questions

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

Are there any openings in this trial for prospective participants?

"Indeed, the information on clinicaltrials.gov indicate that this medical experiment is still recruiting participants. The investigation was originally posted on February 28th 2017 and was most recently adjusted on August 16th 2022. 10 individuals need to be recruited from 2 separate trial sites."

Answered by AI

Does this research protocol permit the participation of adults over 20 years old?

"This experimental trial is recruiting patients between 8 and 22 years of age. There are 76 studies for those under 18, with an additional 344 trials available to adults over 65."

Answered by AI

What is the chief purpose of this examination?

"The principal goal of this research, evaluated from Post ExAblate Procedure to 12 Month Follow-up is to monitor Tumor Volume. Secondary objectives encompass modifications in the physical exam assessed by a physician, patient's subjective judgement of treatment effects and changes observed during confrontational visual field testing performed by a doctor."

Answered by AI

How many individuals are currently participating in this experiment?

"Affirmative. The information on clinicaltrials.gov shows that this experiment is currently enrolling volunteers, with the initial posting being made on February 28th 2017 and the most recent revision occurring on August 16 2022. 10 people are needed to be recruited between 2 separate medical centres."

Answered by AI

Do I meet the criteria for participation in this medical investigation?

"Aspiring participants in this clinical trial must have a brain tumor and fall within the 8-22 year old age bracket. At present, around 10 patients need to be recruited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects

2017. "A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03028246.