Testing an ultrasound device with chemotherapy for glioblastoma that has come back
Official title: Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This trial tests whether opening the brain's natural shield with sound waves helps a chemo drug reach a glioblastoma: The fastest-growing type of glioma (grade 4). Treatment usually starts soon after diagnosis: surgery first, then radiation and chemotherapy. See the glossary that has come back.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT05902169
- Stage of testing
- Phase 3
- Conditions studied
- Glioblastoma, Recurrent Glioblastoma, GBM
Where it is running
This trial lists 55 sites.
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Arizona
- Mayo Clinic Arizona (Phoenix)
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Austria
- Medizinische Universitaet Innsbruck (Innsbruck)
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Belgium
- Universitair Ziekenhuis Brussel (Brussels)
- Universitair Ziekenhuis Leuven (Leuven)
- CHU de Liège (Liège)
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California
- Kaiser Permanente (Los Angeles)
- UCLA (Los Angeles)
- Sutter Health - California Pacific Medical Center (San Francisco)
- University of California, San Francisco (San Francisco)
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Colorado
- UCHealth (Aurora)
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Denmark
- Rigshospitalet (Copenhagen)
- Odense University Hospital (Odense)
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Florida
- Mayo Clinic of Jacksonville Florida (Jacksonville)
- Miami Cancer Institute (Miami)
- Moffitt Cancer Center (Tampa)
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France
- Hôpital Neurologique Pierre Wertheimer (Bron)
- Hôpital de La Timone (Marseille)
- Hôpital de la Pitié-Salpêtrière (Paris)
- Hôpital Foch (Suresnes)
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Georgia
- Winship Cancer Institute at Emory University (Atlanta)
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Germany
- Charité Universitätsmedizin Berlin (Berlin)
- Klinikum Chemnitz gGmbH (Chemnitz)
- Neurochirurgie uniklinik Köln (Cologne)
- Universitätsklinikum Carl Gustav Carus Dresden (Dresden)
- Universitätsklinikum Essen Klinik für Neurologie (Essen)
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Illinois
- Northwestern University (Chicago)
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Indiana
- Indiana University Health (Indianapolis)
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Italy
- Ospedale Bellaria (Bologna)
- Ospedale Civile di Livorno (Livorno)
- Istituto Oncologico Veneto (Padua)
- IFO - Istituto Nazionale Tumori Regina Elena (Roma)
- Irccs Istituto Clinico Humanitas (Rozzano)
- Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino (Torino)
-
Maryland
- John Hopkins University (Baltimore)
-
Minnesota
- Mayo Clinic Rochester (Rochester)
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Netherlands
- Erasmus Medisch Centrum (Erasmus MC) (Rotterdam)
- Haaglanden Medisch Centrum (The Hague)
-
New York
- Weill Cornell Medicine (New York)
- NewYork-Presbyterian / Columbia University Irving Medical Center (New York)
- Lennox Hill Hospital (New York)
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North Carolina
- University of North Carolina (Chapel Hill)
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Ohio
- Neurological Institute Brain Tumor Centre Taussig Cancer Cente (Cleveland)
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Pennsylvania
- Penn State Health Milton S. Hershey Medical Center (Hershey)
-
Spain
- Vall d'Hebron Institute of Oncology (VHIO) (Barcelona)
- Hospital Clinic de Barcelona (Barcelona)
- Hospital Universitario HM Sanchinarro (Madrid)
- Hospital Universitario 12 de Octubre (Madrid)
- Hospital Universitario Virgen del Rocío (Seville)
-
Sweden
- Sahlgrenska University Hospital (Gothenburg)
- Akademiska sjukhuset (Uppsala)
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Switzerland
- Inselspital Bern (Bern)
- Centre Hospitalier Universitaire Vaudois (CHUV) (Lausanne)
-
Texas
- University of Texas Southwestern Medical Center (Dallas)
- University of Texas Houston Health Science Center (Houston)
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Utah
- University of Utah, Hunstman Cancer Institute (Salt Lake City)
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.