NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors

This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for progressive and relapsed diffuse midline glioma (DMG) and other progressive and relapsed high-grade brain tumors. This study combines intravenous nivolumab therapy infused following transient blood-brain barrier opening (BBBO) using low-intensity focused ultrasound with microbubble (LIFU-MB) treatment using NeuroNavigation-Guided Focused Ultrasound (NgFUS). There are two groups in this study: * Group A: Patients with relapsed or progressive diffuse midline glioma in the brainstem * Group B:

Trial Details

NCT ID
NCT07664176
Phase
PHASE1
Sponsor
Children's National Research Institute
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • NeuroNavigation-Guided Focused Ultrasound (NgFUS)
  • Lumason
  • Nivolumab
Locations (sample)
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • Age ≥ 3 and ≤ 25 years.
  • Diagnosis of brainstem DMG/DIPG or any high-grade brain tumor.
  • Group A: Relapsed or progressive brainstem DMG.
  • Group B: Relapsed or progressive high-grade intracranial brain tumor requiring surgical resection.

For full eligibility, visit ClinicalTrials.gov.

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