Testing a sound wave device that briefly opens the brain's protective barrier in people with brain tumors
Official title: Preliminary Clinical Feasibility Study of a Medical Device Enabling Brain Access Using Microbubble-Enhanced Sonication
Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.
The trial team last updated this record on .
The short version
This study is checking whether one treatment with a sound wave device is safe for people with brain tumors.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT07754006
- Stage of testing
- Phase 1
- Conditions studied
- Recurrent Grade 4 Glioma, Brain Metastases From Extra-cranial Solid Tumors
Where it is running
This trial lists 1 site.
-
France
- Gustave Roussy (Villejuif)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.