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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 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.

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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

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

FieldValue
Enrollment Target 10 participants
Start Date 2023-01-04
Est. Completion 2026-06
Phase Phase 1

Sponsor

InSightec

38 total trials

What the Registry Record Tells You About NCT05630209

The ClinicalTrials.gov registry entry for NCT05630209 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 281-participant average among 69 other Brain Tumor trials with a reported enrollment target (96% lower). The listed sponsor is InSightec, which has 38 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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