Diffuse Midline Glioma, H3K27-altered
Conditions
Brief summary
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).
Detailed description
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.
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed