SonoCloud-9 with Carboplatin for Recurrent Glioblastoma

This study is testing a new approach for recurrent glioblastoma (a type of brain cancer). It compares using the SonoCloud-9 device with carboplatin (a chemotherapy drug) against standard chemotherapy options like lomustine or temozolomide. The SonoCloud-9 device uses ultrasound to temporarily open the blood-brain barrier (BBB), a natural shield that prevents many drugs from reaching the brain. By opening the BBB, more carboplatin may be able to get into the tumor. To join, you must have glioblastoma without an IDH mutation and have already received prior surgery/biopsy and radiation. The main goal is to see if this new approach helps people live longer. The study aims to enroll 560 participants, but its current status is unclear.

Study design
This interventional study is comparing two treatment approaches for recurrent glioblastoma, aiming to enroll 560 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure overall survival for up to 24 months.

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NCT05902169

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

Recruiting
PHASE3Ages 18+InterventionalTreatment
CarThera
~560 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:SonoCloud-9 (SC9)CarboplatinLomustineTemozolomide

At a glance

Recruiting sites
43 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over Up to 24 months
Glioblastoma
Recurrent Glioblastoma
GBM
55 sites across 25 states
Italy6
Germany5
Spain5
California4
France4
Florida3
New York3
Belgium3

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Eligibility criteria

Inclusion

Cytotoxic
Other small chemical entity (e.g., targeted therapy)
For biologics (e.g., antibodies, except bevacizumab) 2. ≥ 6 weeks of prior bevacizumab 9. Adequate hematologic, hepatic, and renal laboratory values within 14 days prior to inclusion§ i.e.:
  • Overall survival (OS)Up to 24 months

    Survival status will be collected during the treatment period, for up to 7 months (short-term follow-up) and then every 3 months as standard of care follow-up (long-term follow-up) until participant's 'End of Study', defined as end of survival follow-up period, death, withdrawal of consent for the collection of data, or 'lost to follow-up' (whichever comes first).