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NCT04804709 · ClinicalTrials.gov registry record · Phase 1
Non-Invasive Focused Ultrasound (FUS) With Oral Panobinostat in Children With Progressive Diffuse Midline Glioma (DMG)
A Phase 1 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04804709 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 5 participants.
The verdict
NCT04804709, a Phase 1 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
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 BBB in children with progressive diffuse midline gliomas (DMG) treated with oral Panobinostat using FUS with microbubbles and neuro-navigator-controlled sonication. For the purpose of the study, the investigators will be opening up the BBB temporarily in one, two, or three locations around the tumor using the non-invasive FUS technology, and administrating oral Panobinostat in children with progressive DMG.
Interventions
- DRUG Panobinostat 15 MG
- DEVICE Focused Ultrasound with neuro-navigator-controlled sonication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04804709
The ClinicalTrials.gov registry entry for NCT04804709 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Panobinostat 15 MG is the first listed.
NCT04804709 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04804709 about?
NCT04804709 is a clinical study titled "Non-Invasive Focused Ultrasound (FUS) With Oral Panobinostat in Children With Progressive Diffuse Midline Glioma (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 NCT04804709?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2021-07-28. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT04804709?
The interventions under investigation include: Panobinostat 15 MG (DRUG), Focused Ultrasound with neuro-navigator-controlled sonication (DEVICE).
Who is sponsoring clinical trial NCT04804709?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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