Clinical trial · Interventional
Safety of BBB Opening With the SonoCloud
A Study to Evaluate the Safety of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SonoCloud Implantable Device in Patients With Recurrent Glioblastoma Before Chemotherapy Administration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PURPOSE: The purpose of this study is to determine whether transient opening of the blood-brain barrier by pulsed ultrasound using the SonoCloud implantable ultrasound device is safely tolerated in patients with recurrent glioblastoma immediately before systemic delivery of carboplatin-based chemotherapy. STUDY HYPOTHESIS: The blood-brain barrier can be safely opened using pulsed ultrasound prior to chemotherapy administration in patients with recurrent glioblastoma. Transient opening of the blood-brain barrier by pulsed ultrasound will increase the glioblastoma exposure to carboplatin-based chemotherapy and increase progression-free and overall survival in patients with recurrent glioblastoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| SonoCloud | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SonoCloud + carboplatin
- description
- SonoCloud : dose escalation Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC
- interventionNames
- Device: SonoCloud
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Safety of transient disruption of the blood-brain barrier using the SonoCloud system in patients with recurrent glioblastoma.
- timeFrame
- 12 months
Secondary outcomes (4)
- measure
- Maximum tolerated dose of ultrasound with the SonoCloud system for transient disruption of the BBB.
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Age greater than 18 years. * Subjects with recurrent glioma who have failed standard therapy with surgery and/or treatment with radiation and temozolomide. * Patient eligible for Carboplatin-based chemotherapy * Contrast-enhanced tumor less than 35 mm in diameter * No risk of cerebral herniation * Able to tolerate pre/post procedure steroid treatment * Social security affiliated (in France) * Able and willing to give signed and informed consent * Normal biological status * Hemoglobin ≥ 10 g/dl * Platelets ≥ 100000/mm3 * Neutrophils ≥ 1500/mm3 * Normal creatine clearance ≥ 60ml/mn * ASAT \< 3 N * ALAT \< 3 N * Normal Bilirubin Level \< 1.5 N * Alkaline Phosphatase \< 3 N * INR \< 1.5 * Prothrombin Level ≥ 70% Exclusion criteria: * Allergic to Iodine, Gadolinium, Xylocain * Contra-indications to echographic contrast agent (microbubbles) * Severe Renal insufficiency * Hepatic insufficiency * Possible toxic treatment for CNS * Previously infected surgical field * Uncontrolled epilepsy * MRI contra-indications * Hemostasis troubles thrombopenia \<75.000, TP \<60%, INR \>1.5, anti-platelet or anticoagulant therapy on-going) * Active phlebitis or active pulmonary embolism * Pregnant or currently breast-feeding * Patients under judicial protection
References
Publications (2)
- DERIVEDAsquier N, Bouchoux G, Canney M, Martin C, Law-Ye B, Leclercq D, Chapelon JY, Lafon C, Idbaih A, Carpentier A. Blood-brain barrier disruption in humans using an implantable ultrasound device: quantification with MR images and correlation with local acoustic pressure. J Neurosurg. 2019 Feb 1;132(3):875-883. doi: 10.3171/2018.9.JNS182001. Print 2020 Mar 1. PMID 30717050
- DERIVEDGoldwirt L, Canney M, Horodyckid C, Poupon J, Mourah S, Vignot A, Chapelon JY, Carpentier A. Enhanced brain distribution of carboplatin in a primate model after blood-brain barrier disruption using an implantable ultrasound device. Cancer Chemother Pharmacol. 2016 Jan;77(1):211-6. doi: 10.1007/s00280-015-2930-5. Epub 2015 Dec 8. PMID 26645405