CAMPSIS is a preliminary feasibility study of the TheraOne medical device (IIb). TheraOne is an active, non-invasive medical device intended to deliver transcranial FUS in combination with intravenous microbubbles in order to transiently and locally induce the BBB permeability.
This study aims to evaluate the safety of cerebral sonication (TheraOne) in the management of patients with recurrent grade 4 glioma (wild-type IDH, technically resectable) or brain metastases originating from an extracranial solid tumor.
Patients enrolled in the study will undergo a single sonication session during a protocol visit and will be monitored for up to 30 days after the sonication through the various scheduled protocol visits.
Blood samples will be collected at the start of the study, during the sonication, and during the post-sonication follow-up visit for all patients enrolled in the study.
Age: ≥18 years old.
Performance Status: Karnofsky Performance Score (KPS) ≥ 70%.
Patient with an expansive intra-cerebral tumor showing enhancement after gadolinium injection on MRI (T1-weighted images, with and without gadolinium contrast).
Recurrent High-Grade glioma (excluding prosthetic material), or a brain metastasis from extracranial solid primary.
Acute mass effect with ≥5 mm midline shift or basal cistern effacement.
Severe peritumoral edema causing acute intracranial hypertension or compression of critical structures.
Hemorrhagic transformation or necrosis with a high risk of rupture.
Significant tumor volume outside the treatment envelope.