Actively Recruiting
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Led by CarThera · Updated on 2026-04-24
560
Participants Needed
48
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.
CONDITIONS
Official Title
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed glioblastoma without IDH mutation
- Prior surgery or biopsy and standard or hypofractionated radiotherapy completed
- At least one line of maintenance chemotherapy or immune/biological therapy received
- First unequivocal disease progression with measurable tumor documented by MRI within 14 days
- Minimum 12 weeks since last radiotherapy, unless new lesion or confirmed viable tumor
- Candidate for craniotomy and at least 50% resection of enhancing tumor
- Maximum tumor diameter prior to inclusion is 5 cm or less
- WHO performance status 2 or better (Karnofsky 70 or higher)
- Age 18 years or older
- Recovered from acute toxic effects of prior anticancer therapies according to specified intervals
- Adequate blood counts, liver and kidney function within 14 days
- Able to understand trial and provide informed consent
- Negative pregnancy test if of childbearing potential and agree to birth control
- Male patients agree to condom use and refrain from sperm donation during and after treatment
- Covered by a health plan and social security scheme as required
You will not qualify if you...
- Multifocal enhancing tumor outside a 5 cm diameter area
- Tumor located in the posterior fossa
- Known BRAF or NTKR mutations
- Risk factors for surgical site infection or recent multiple neurosurgeries
- Use of high or stable dose corticosteroids above specified levels prior to inclusion
- Contraindication to carboplatin, lomustine, or temozolomide
- Known allergies to ultrasound resonator components
- Previous bevacizumab treatment for reasons other than edema
- Peripheral neuropathy grade 2 or higher
- Uncontrolled epilepsy or intracranial pressure
- Known intracranial aneurysm or significant hemorrhage
- Presence of unremovable implants such as coils, clips, or stents
- Need for continuous antiplatelet or anticoagulation therapy without possible interruption
- Use of enzyme-inducing antiepileptic drugs unless switched to other regimens
- Other malignancies within last 3 years except certain skin or cervical cancers
- Active or chronic infections
- Significant cardiac or pulmonary conditions
- Known sensitivity to gadolinium or contrast agents
- Impaired temperature regulation or sensation
- Pregnancy or breastfeeding
- Any serious medical or psychological condition affecting treatment or evaluation
- Legal guardianship or deprivation of liberty
- Major medical illnesses impairing ability to receive treatment or confounding evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 48 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 805054
Active, Not Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94143
Active, Not Recruiting
3
UCHealth
Aurora, Colorado, United States, 80011
Active, Not Recruiting
4
Mayo Clinic of Jacksonville Florida
Jacksonville, Florida, United States, 32224
Active, Not Recruiting
5
Miami Cancer Institute
Miami, Florida, United States, 33176
Active, Not Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
7
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
8
Northwestern University
Chicago, Illinois, United States, 60611
Active, Not Recruiting
9
Indiana University Health
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
10
John Hopkins University
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
11
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
12
Weill Cornell Medicine
New York, New York, United States, 10021
Active, Not Recruiting
13
NewYork-Presbyterian / Columbia University Irving Medical Center
New York, New York, United States, 10032
Active, Not Recruiting
14
Lennox Hill Hospital
New York, New York, United States, 10075
Active, Not Recruiting
15
University of North Carolina
Chapel Hill, North Carolina, United States, 27516
Active, Not Recruiting
16
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Active, Not Recruiting
17
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Active, Not Recruiting
18
University of Texas Houston Health Science Center
Houston, Texas, United States, 77030
Active, Not Recruiting
19
University of Utah, Hunstman Cancer Institute
Salt Lake City, Utah, United States, 84112
Active, Not Recruiting
20
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Active, Not Recruiting
21
Universitair Ziekenhuis Brussel
Brussels, Belgium
Actively Recruiting
22
Universitair Ziekenhuis Leuven
Leuven, Belgium
Active, Not Recruiting
23
CHU de Liège
Liège, Belgium
Actively Recruiting
24
Rigshospitalet
Copenhagen, Denmark, 2100
Active, Not Recruiting
25
Odense University Hospital
Odense, Denmark, 5000
Active, Not Recruiting
26
Hôpital Neurologique Pierre Wertheimer
Bron, France
Active, Not Recruiting
27
Hôpital de La Timone
Marseille, France
Actively Recruiting
28
Hôpital de la Pitié-Salpêtrière
Paris, France
Actively Recruiting
29
Hôpital Foch
Suresnes, France, 92150
Active, Not Recruiting
30
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Active, Not Recruiting
31
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09113
Active, Not Recruiting
32
Neurochirurgie uniklinik Köln
Cologne, Germany
Active, Not Recruiting
33
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Active, Not Recruiting
34
Universitätsklinikum Essen Klinik für Neurologie
Essen, Germany, 45147
Active, Not Recruiting
35
Ospedale Bellaria
Bologna, Italy, 40139
Active, Not Recruiting
36
Ospedale Civile di Livorno
Livorno, Italy, 57124
Active, Not Recruiting
37
Istituto Oncologico Veneto
Padua, Italy
Active, Not Recruiting
38
Irccs Istituto Clinico Humanitas
Rozzano, Italy, 20089
Active, Not Recruiting
39
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Active, Not Recruiting
40
Erasmus Medisch Centrum (Erasmus MC)
Rotterdam, Netherlands
Active, Not Recruiting
41
Haaglanden Medisch Centrum
The Hague, Netherlands, 2263
Active, Not Recruiting
42
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain, 08035
Active, Not Recruiting
43
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Active, Not Recruiting
44
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Active, Not Recruiting
45
Hospital Universitario 12 de Octubre
Madrid, Spain
Active, Not Recruiting
46
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Active, Not Recruiting
47
Inselspital Bern
Bern, Switzerland, 3010
Active, Not Recruiting
48
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland, 1011
Active, Not Recruiting
Research Team
C
Carole Desseaux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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