FIDES: Focused Ultrasound-mediated Blood-Brain Barrier Opening In Pontine Diffuse Midline Glioma (DMG) to Enhance Systemic Therapy with Temozolomide – an exploratory pilot and feasibility trial

Condition studied

Diffuse Midline Glioma, H3K27-altered

Investigational medicinal product(s)

Every trial of Temozolomide across our registers →

Eligibility

Primary endpoint

Any serious adverse events (SAE) related to the Exablate BBBO device- and procedure, classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0., Proportion of patients alive and progression-free at 6 months, based on standardized imaging criteria (e.g., RANO or RAPNO for DMG).

Endpoint detail

Time from diagnosis to disease progression or death, measured by standardized criteria (e.g., RANO/RAPNO)., Time from diagnosis to death from any cause., Radiological response rate according to the response assessment in neuro-oncology criteria (RANO and RAPNO criteria), Extent and consistency of BBB opening as confirmed by T1-weighted contrast-enhanced MRI after each Exablate BBBO session., Incidence of adverse events (AE) over time related to the Exablate BBBO device- and procedure, classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.