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Procedure

ExAblate BBBD for Brain Tumor (BBBD Trial)

N/A
Waitlist Available
Led By Nir Lipsman, MD
Research Sponsored by InSightec
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 throughout the study, approximately 10 months.
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to evaluate the safety of BBB disruption using the ExAblate 4000-system Type 2 in patients with Her-2 positive breast cancer metastases in the brain.

Eligible Conditions
  • Breast Cancer
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, approximately 10 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, approximately 10 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Secondary study objectives
Feasibility of BBBD

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: ExAblate BBBDExperimental Treatment1 Intervention
Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases

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Who is running the clinical trial?

InSightecLead Sponsor
91 Previous Clinical Trials
3,788 Total Patients Enrolled
Nir Lipsman, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
64 Total Patients Enrolled
~2 spots leftby Nov 2025
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