CAMPSISNCT07754006

Preliminary Clinical Feasibility Study of a Medical Device Enabling Brain Access Using Microbubble-Enhanced Sonication

StatusRecruiting

PhasePhase 1

SponsorGustave Roussy, Cancer Campus, Grand Paris

Primary completionSep 2027 (estimated)

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 10, 2026 Recruitment opened
- Start date: Sep 2026 to Nov 2026
- Eligibility criteria expanded, about 122 words
- Site details revised
Aug 6, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Safety : evaluating the occurrence and severity of adverse events related to the sonication procedure

Timeframe: Up to 14 days after the sonication

Secondary (2)

Feasibility : completion rate of sonication phase

BBB permeability assessment by several MRI imaging at predefined timepoints.

Arms and interventions

Patients with recurrent grade 4 glioma or brain metastasis from an extracranial solid tumorExperimental

Procedures: Temporarily and locally induce permeability of the blood-brain barrier (sonication) using TheraOne

Sites

1 site in 1 country

Gustave RoussyVillejuif, France, France

About this trial

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.

Trial details

Enrollment: 6 participants (estimated)
Started: Nov 2026
Study completion: Oct 2027 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, open label, other
Oversight: No data monitoring committee
Conditions: Recurrent Grade 4 Glioma, Brain Metastases From Extra-cranial Solid Tumors
Official title: Cerebral Access Using Microbubble Potentiated Sonication: Initial Study
First posted: Aug 10, 2026
Registry updated: Nov 12, 2026
Last verified: Nov 2026

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