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NCT05630209 · ClinicalTrials.gov registry record · Phase 1
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)
A Phase 1 study of Brain Tumor, sponsored by InSightec.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT05630209: Recruiting Phase 1 study of Brain Tumor, sponsored by InSightec.
NCT05630209 is a Phase 1 study of Brain Tumor that is actively recruiting participants, run by InSightec. The registered enrollment target is 10 participants, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05630209, a Phase 1 study of Brain Tumor, is actively recruiting participants, sponsored by InSightec.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
Study Summary
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
Primary Outcome
All adverse events from first treatment to end of study will be documented and reported according to the CTCAE terminology and severity scale
Conditions Studied
Interventions
- DRUG Doxorubicin
- DEVICE Exablate
Study Locations (3)
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Nicklaus Children's Hospital - Miami
Texas
- Cook Children's Health Care System - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-01-04 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT05630209 shows while recruiting
NCT05630209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Brain Tumor appearing as the primary indexed condition, and to 2 interventions - of which Doxorubicin is the first listed.
NCT05630209 reports a single indexed study location in District of Columbia, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05630209 about?
NCT05630209 is a clinical study titled "Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)". 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
What is the current status of trial NCT05630209?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-01-04. Estimated completion is 2026-06.
What conditions does trial NCT05630209 study?
This clinical trial studies the following conditions: Brain Tumor.
What interventions are being tested in trial NCT05630209?
The interventions under investigation include: Doxorubicin (DRUG), Exablate (DEVICE).
Who is sponsoring clinical trial NCT05630209?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05630209 being conducted?
This trial has 3 study locations across District of Columbia, Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05630209's enrollment target sits among peer trials
10 64th of 69 higher than 4 of 69 other Brain Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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