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NCT02372409 · ClinicalTrials.gov registry record · Phase 2
Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT02372409 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 6 participants.
The verdict
NCT02372409, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics whereby the investigators can measure and identify the window of maximal BBB disruption post MLA to 1) allow for an alternative to surgery in incompletely resected tumors, 2) allow for optimal chemotherapeutic dosing to achieve the greatest benefits and the least systemic side effects and 3) distinguish subsequent tumor progression from long-term MLA treatment effects. Preliminary data in adult imaging studies have shown that the BBB disruption lasts for several weeks following treatment before returning to a low baseline. This pilot therapeutic study will provide preliminary validation in pediatric patients.
Interventions
- DRUG Doxorubicin
- DRUG Etoposide
- DEVICE MRI-guided laser ablation
- DEVICE Dynamic contrast-enhanced (DCE) MRI
- DEVICE Dynamic susceptibility contrast (DSC) MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-08-14 |
| Est. Completion | 2023-03-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02372409
The ClinicalTrials.gov registry entry for NCT02372409 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Doxorubicin is the first listed.
NCT02372409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02372409 about?
NCT02372409 is a clinical study titled "Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors". By employing a combination of advanced MRI techniques and correlative serum biomarkers of blood brain barrier (BBB) disruption, the investigators plan to develop a powerful, first of its kind clinical algorithm in pediatrics whereby the investigators can measure and identify the window of maximal BB...
What is the current status of trial NCT02372409?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2015-08-14. Estimated completion is 2023-03-23.
What interventions are being tested in trial NCT02372409?
The interventions under investigation include: Doxorubicin (DRUG), Etoposide (DRUG), MRI-guided laser ablation (DEVICE), Dynamic contrast-enhanced (DCE) MRI (DEVICE), Dynamic susceptibility contrast (DSC) MRI (DEVICE).
Who is sponsoring clinical trial NCT02372409?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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