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Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)

StatusActive, Not Recruiting
PhasePhase 1/2
SponsorInSightec
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 17, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Jan 2026 to Jun 2026 · Completion date: Jun 2026 to Oct 2026 · Site details revised at 3 of 3 sitesv9 Show 3 more changesShow less
    • Primary completion date: Jan 2026 to Jun 2026
    • Completion date: Jun 2026 to Oct 2026
    • Site details revised at 3 of 3 sites
  2. Site contacts updated at 1 of 3 sitesv8
  3. Site contacts updated at 1 of 3 sitesv7
  4. Study sites: 2 to 3v6
  5. Primary completion date: Jan 2025 to Jan 2026 Completion date: Jan 2026 to Jun 2026 · Eligibility criteria expanded, about 18 words · Site contacts updated at 1 of 2 sites · 1 morev5 Show 4 more changesShow less
    • Completion date: Jan 2026 to Jun 2026
    • Eligibility criteria expanded, about 18 words
    • Site contacts updated at 1 of 2 sites
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 1 to 2 Start date changed from estimate of Feb 2023 to Jan 4, 2023v4 Show 1 more changeShow less
    • Start date changed from estimate of Feb 2023 to Jan 4, 2023
  2. Start date: Dec 2022 to Feb 2023 Primary completion date: Dec 2024 to Jan 2025 · Completion date: Dec 2025 to Jan 2026 · Site contact updatedv3 Show 3 more changesShow less
    • Primary completion date: Dec 2024 to Jan 2025
    • Completion date: Dec 2025 to Jan 2026
    • Site contact updated
  3. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
InSightec
42 trials monitored
See 1 trial at risk
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric patients
Trial Details
NCT Number NCT05630209
Lead Sponsor InSightec
Conditions Brain Tumor
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov