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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: Recruiting Phase 1 study of Diffuse Intrinsic Pontine Glioma and Diffuse Midline Glioma, H3 K27M-Mutant, sponsored by Columbia University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is to evaluate the safety of using focused ultrasound to open the blood brain barrier at one or two sites for administration of etoposide in children with progressive diffuse midline glioma. Safety will be assessed by adverse events as per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (including abnormalities from physical and neurologic examinations, laboratory values, and radiographic results).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT05762419 shows while recruiting
NCT05762419 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 135-participant average among 28 other Diffuse Intrinsic Pontine Glioma trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05762419's enrollment target sits among peer trials
10 27th of 28 higher than 2 of 28 other Diffuse Intrinsic Pontine Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Intrinsic Pontine Glioma 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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