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NCT02343991 · ClinicalTrials.gov record · last posted 2025-05-01

Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound

StatusActive, Not Recruiting
PhaseNot applicable
SponsorInSightec
Started2014-10
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this study is to evaluate the safety of BBB disruption using transcranial MRI-guided focused ultrasound in conjunction with an intravenous ultrasound contrast agent to increase the accumulation of doxorubicin in brain tumours and the adjacent brain using the ExAblate Transcranial system (220 kHz). Data will be collected to establish the basic safety of this type of treatment as the basis for later studies to evaluate its clinical efficacy.

Amendment record 8 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 8 times since 2015-01-16; most recent amendment 2025-04-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2019-01-08
Status change Recruiting→Active, Not Recruitingv5
Trial Details
NCT Number NCT02343991
Lead Sponsor InSightec
Conditions Brain Tumor
Enrollment 10 participants
Start Date 2014-10
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-01