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NCT05762419 · ClinicalTrials.gov registry record · Phase 1

FUS Etoposide for DMG

A Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, sponsored by Columbia University.

Recruiting
Registry status
Phase 1
Development phase
10
Enrollment target
1
Study location

NCT05762419 is a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant that is actively recruiting participants, run by Columbia University. The registered enrollment target is 10 participants, below the 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05762419, a Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, is actively recruiting participants, sponsored by Columbia University.

RECRUITING
Registry status
Phase 1
Development phase
10 participants
Enrollment target
1
Study location

Study Summary

The blood brain barrier (BBB) prevents some drugs from successfully reaching the target tumor. Focused Ultrasound (FUS) using microbubbles and neuro-navigator controlled sonication is a non-invasive method of temporarily opening up the blood brain barrier to allow a greater concentration of the drug to reach into the brain tumor. This may improve response and may also reduce system side effects in the patient. The primary purpose of this study is to evaluate the feasibility of safely opening the blood brain barrier in children with progressive diffuse midline gliomas (DMG) treated with oral etoposide using focused ultrasound with microbubbles and neuro-navigator-controlled sonication. For the purpose of the study, the investigators will be opening up the blood brain barrier temporarily in one or two locations around the tumor using the non-invasive focused ultrasound technology, and administrating oral etoposide in children with progressive diffuse midline glioma.

Conditions Studied

Diffuse Intrinsic Pontine Glioma Diffuse Midline Glioma, H3 K27M-Mutant

Interventions

  • DRUG Etoposide; Oral, 50 Mg
  • DEVICE Focused ultrasound with neuro-navigator-controlled sonication

Study Locations (1)

New York

  • Columbia University Irving Medical Center - New York

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2023-06-05
Est. Completion 2027-12
Phase Phase 1

Sponsor

Columbia University

958 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05762419

The ClinicalTrials.gov registry entry for NCT05762419 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 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (93% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Diffuse Intrinsic Pontine Glioma appearing as the primary indexed condition, and to 2 interventions - of which Etoposide; Oral, 50 Mg is the first listed.

NCT05762419 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT05762419 about?

NCT05762419 is a clinical study titled "FUS Etoposide for DMG". The blood brain barrier (BBB) prevents some drugs from successfully reaching the target tumor. Focused Ultrasound (FUS) using microbubbles and neuro-navigator controlled sonication is a non-invasive method of temporarily opening up the blood brain barrier to allow a greater concentration of the drug...

What is the current status of trial NCT05762419?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2023-06-05. Estimated completion is 2027-12.

What conditions does trial NCT05762419 study?

This clinical trial studies the following conditions: Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant.

What interventions are being tested in trial NCT05762419?

The interventions under investigation include: Etoposide; Oral, 50 Mg (DRUG), Focused ultrasound with neuro-navigator-controlled sonication (DEVICE).

Who is sponsoring clinical trial NCT05762419?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05762419 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.