Focused ultrasound using oral etoposide for Diffuse Intrinsic Pontine Glioma
Study Summary
This trial will assess whether FUS can safely open the blood brain barrier, allowing a greater concentration of the drug to reach into the brain tumor, potentially improving response and reducing side effects.
- Diffuse Intrinsic Pontine Glioma
- Diffuse Intrinsic Pontine Glioma (DIPG)
- Diffuse Midline Glioma, H3 K27M-Mutant
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: Treatment will consist of up to 4 cycles, each lasting 28 days. During the first 2 weeks of each cycle, subjects will receive FUS therapy for a maximum of 3 times per week, concurrent with etoposide.
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Focused ultrasound using oral etoposide
1 of 1
Experimental Treatment
10 Total Participants · 1 Treatment Group
Primary Treatment: Focused ultrasound using oral etoposide · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 4 - 21 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Is the age range for this research restricted to adults under 45?
"This clinical trial is enrolling participants between the ages of four and twenty-one." - Anonymous Online Contributor
Is there an opportunity for me to join this investigation?
"Potential participants in this study must have diffuse intrinsic pontine glioma and be aged between 4 and 21. The trial is accepting around 10 people on a first come, first served basis." - Anonymous Online Contributor
Does this experiment need more participants at present?
"Data published on clinicaltrials.gov reveals that this research endeavour is actively seeking participants, which was first announced March 1st 2023 and last updated February 28th 2023." - Anonymous Online Contributor
How many participants have been recruited to partake in this experiment?
"Indeed, the information provided on clinicaltrials.gov suggests that this medical research is currently in search of participants. This experiment was initially shared online on March 1st 2023 and underwent a revision at the end of February 2023. The team behind this trial plans to enrol 10 patients from one site." - Anonymous Online Contributor
Has the FDA authorized using oral etoposide for Focused ultrasound treatment?
"Our team's assessment of the safety profile of Focused Ultrasound using oral etoposide is a 1, as it has only been tested in preliminary clinical trials. As such, there is limited data to support its efficacy and safety." - Anonymous Online Contributor
What goals are researchers looking to achieve with this experiment?
"The primary purpose of this trial is to establish the number of patients who experience successful permeability of their blood-brain barrier. This will be evaluated approximately 90 days after completion of focused ultrasound treatment. Further, a secondary objective includes 3-month overall survival which refers to the period between initial treatment and death from any cause. To measure this outcome, participants will have follow up visits at intervals ranging from every three to six months or until passing away for whatever reason. An additional aim focuses on imaging changes in regards to the BBB/Tumor and identifying severe or serious adverse events with CTCAE version 5.0 noting that throm" - Anonymous Online Contributor