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

NCT07754006 | Not Yet Recruiting Phase 1

• 2 other identifiers: 2025-A02389-402026/4280
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Grade 4 Glioma; Brain Metastases From Extra-cranial Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

  Up to 14 days after the sonication

Secondary Outcomes (2)

• Feasibility : completion rate of sonication phase

  Immediately after the procedure.

• BBB permeability assessment by several MRI imaging at predefined timepoints.

  Up to 14 days after the sonication

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥18 years old.
• Performance Status: Karnofsky Performance Score (KPS) ≥ 70%.
• Tumor Characteristics:
• Patient with an expansive intra-cerebral tumor showing enhancement after gadolinium injection on MRI (T1-weighted images, with and without gadolinium contrast).
• Tumor radiologically classified as:
• Recurrent High-Grade glioma (excluding prosthetic material), or a brain metastasis from extracranial solid primary.
• Measuring at least 25-30 mm in the longest axis.
• In both cases, Surgery is not required as a first-line option. However, the target lesion must be considered technically operable (non-eloquent location)
• In the case of brain metastases, multifocal disease is allowed, provided that additional metastases are smaller to 20 mm, not neurologically threatening, and do not require surgery. Cases of leptomeningeal invasion are not allowed.
• Tumor should not exhibit signs of rapid progression or acute neurological compromise requiring urgent intervention. Rapid progression is defined as a ≥25% increase in contrast-enhancing tumor volume within 4 weeks, associated with mass effect or new edema. Acute neurological compromise includes any newly developed or worsening neurological deficit (e.g., motor weakness, aphasia), seizures refractory to antiepileptics, decreased level of consciousness (Glasgow Coma Scale (GCS) \<13), or signs of intracranial hypertension.
• Operability and Location:
• Target Tumor is deemed operable by the neurosurgeon and is located in a non-eloquent area (e.g., excluding brainstem or regions associated with critical motor or speech function).
• Tumor must be located in the cortical or subcortical regions, at least 20 mm beneath the inner skull surface to ensure accessibility to the TheraOne intervention.
• In case of brain metastasis, extracerebral disease must be absent or at least controlled, defined as:
• A Positron Emission Tomography (PET) scan performed within 6 weeks showing resolution of hyperintensity, or

You may not qualify if:

• Tumor imaging features suggestive of:
• 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.
• Tumor morphology or imaging findings that preclude the ability to sonicate the tumor volume, including:
• Significant tumor volume outside the treatment envelope.
• Tumor volume exceeding the maximum allowed sonication volume (currently 110 ccs at the treatment volume level).
• Concerns about adequate tumor coverage by sonication based on tumor morphology should be discussed with the Sponsor.
• Vascular \& Hemorrhagic Conditions:
• Cerebrovascular disease history:
• Untreated arteriovenous malformation (AVM).
• Untreated or unstable cerebral aneurysm.
• Acute hemorrhage or cystic lesions:
• Evidence of acute intracranial hemorrhage.
• Presence of a cyst within the region of interest (ROI).

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, France, 94800, France

Location

MeSH Terms

Interventions

Sonication

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Sophie Bockel, MD, PhD

CONTACT

+33 (0)1 42 11 42 11; sophie.bockel@gustaveroussy.fr

Ophélie Lion

CONTACT

+33 (0)1 42 11 48 41; ophelie.lion@gustaveroussy.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

FR (1)