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Focused Ultrasound + Chemotherapy for Pediatric Brain Cancer
Study Summary
This trial will study the safety and effectiveness of a new DIPG treatment combining ultrasound and chemotherapy in children.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an infection in my brain or elsewhere in my body.I have a history of bleeding disorders or my tumor has bled on its own.I am between 5 and 18 years old.The tumor cannot be seen on any imaging before or after radiation treatment.It's been over 2 weeks since my brain surgery, and I've fully recovered without any neurological issues.I cannot take Doxorubicin due to health reasons.My blood pressure is high for my age.My scans after radiation show no signs of tissue death or bleeding that would prevent MRgFUS treatment.I am not currently taking blood thinners or medications that increase bleeding risk.I am allergic to DEFINITY® or its ingredients like polyethylene glycol.I have received full doses of specific chemotherapy drugs before.I have a severe illness that threatens my life.You are allergic to gadolinium-based contrast agents.I have a blood vessel disorder in my brain or body.I have had seizures that medication couldn't control for at least 4 weeks.I have been on a stable or decreasing dose of steroids for at least a week.I am not on immunosuppression, except for steroids for brain swelling.You have HIV.I experience symptoms like headaches or vision changes due to high pressure in my brain.I have been in early-stage trials for cancer treatment before.I finished my radiation therapy between 4 to 12 weeks ago.I am currently on Avastin therapy or taking higher doses of steroids.I have been diagnosed with a brain tumor known as DIPG.
- Group 1: Blood Brain Barrier Disruption (BBBD)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still opportunities to participate in this research endeavor?
"Data listed on clinicaltrials.gov demonstrates that this research is actively seeking to enrol participants. Initially published on the 10th of December 2022 and last modified 18 days later, it is now available for volunteers."
What is the maximum capacity of participants in this medical study?
"Yes, the information on clinicialtrials.gov indicates that this trial is actively recruiting subjects. It was initially published on December 10th 2022 and has been updated as recently as November 18th 2022. The study requires 3 participants to be found at 1 medical institution."
Is it possible for individuals younger than 35 to enroll in this clinical trial?
"This research opportunity is open to participants aged between 5 and 18 years old."
To which demographic is eligibility for this experiment restricted?
"This clinical trial seeks 3 juvenile and adolescent patients who have been diagnosed with DIPG. To be eligible for the study, candidates must meet a number of conditions: Age between 5 to 18 years old; Completion of radiation therapy no longer than 12 weeks ago; No evidence on post-radiation imaging contraindicating MRgFUS; Capacity to attend all visits and life expectancy over 6 months; Ability or legal guardianship capacity to provide consent/assent, if applicable; Steroid dose stability for at least 7 days preceding enrollment (if steroids are in use); At least 14 days passed since any previous brain surgery with full"
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