Plain-English translation of NCT05293197 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This study tests a new implantable device called SonoCloud® that uses ultrasound to temporarily open the blood-brain barrier—a protective layer that usually blocks most medicines from reaching the brain. By opening this barrier at the right time, chemotherapy medicine can reach brain tumors more effectively. The trial will check whether this treatment is safe and well-tolerated in children and teens with hard-to-treat brain tumors.
Brain tumors are the leading cause of cancer death in children, and one major reason is the blood-brain barrier, which prevents most cancer-fighting drugs from reaching the tumor. This medication aims to solve that problem by using ultrasound to temporarily open the barrier so chemotherapy can work better.
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You would have surgery to place the small SonoCloud® device under your scalp, where it will remain throughout treatment. Over 6 months, you will receive multiple treatment cycles combining the ultrasound activation (synchronized with your chemotherapy doses) and regular MRI scans to monitor how well it's working. If you tolerate the treatment well, you may continue for up to 6 additional cycles. The device is designed to be invisible and compatible with MRI, allowing outpatient treatment without major disruption to your daily life.
AI-generated summary from trial data · Aug 14, 2026 · Not medical advice
France