Blood Brain Barrier Disruption (BBBD) for Brain Tumor

Phase-Based Progress Estimates
Sunnybrook Research Institute, Toronto, CanadaBrain TumorExablate - Device
5 - 18
All Sexes
What conditions do you have?

Study Summary

This trial will study the safety and effectiveness of a new DIPG treatment combining ultrasound and chemotherapy in children.

Eligible Conditions
  • Brain Tumor

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 2 years

2 years
Adverse Events
Progression Free Survival (PFS) and Overall Survival (OS)
Immediately post BBBD sonication
Tumor Volume

Trial Safety

Trial Design

1 Treatment Group

Blood Brain Barrier Disruption (BBBD)
1 of 1

Experimental Treatment

3 Total Participants · 1 Treatment Group

Primary Treatment: Blood Brain Barrier Disruption (BBBD) · No Placebo Group · Phase 1 & 2

Blood Brain Barrier Disruption (BBBD)Experimental Group · 2 Interventions: Exablate, Doxorubicin · Intervention Types: Device, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

InSightecLead Sponsor
86 Previous Clinical Trials
3,543 Total Patients Enrolled

Eligibility Criteria

Age 5 - 18 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with diffuse intrinsic pontine glioma (DIPG).

Frequently Asked Questions

Are there still opportunities to participate in this research endeavor?

"Data listed on demonstrates that this research is actively seeking to enrol participants. Initially published on the 10th of December 2022 and last modified 18 days later, it is now available for volunteers." - Anonymous Online Contributor

Unverified Answer

What is the maximum capacity of participants in this medical study?

"Yes, the information on indicates that this trial is actively recruiting subjects. It was initially published on December 10th 2022 and has been updated as recently as November 18th 2022. The study requires 3 participants to be found at 1 medical institution." - Anonymous Online Contributor

Unverified Answer

Is it possible for individuals younger than 35 to enroll in this clinical trial?

"This research opportunity is open to participants aged between 5 and 18 years old." - Anonymous Online Contributor

Unverified Answer

To which demographic is eligibility for this experiment restricted?

"This clinical trial seeks 3 juvenile and adolescent patients who have been diagnosed with DIPG. To be eligible for the study, candidates must meet a number of conditions: Age between 5 to 18 years old; Completion of radiation therapy no longer than 12 weeks ago; No evidence on post-radiation imaging contraindicating MRgFUS; Capacity to attend all visits and life expectancy over 6 months; Ability or legal guardianship capacity to provide consent/assent, if applicable; Steroid dose stability for at least 7 days preceding enrollment (if steroids are in use); At least 14 days passed since any previous brain surgery with full" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.