Sound waves open brain barrier to attack deadly tumor

NCT ID NCT05902169

Disease control Sponsor: CarThera Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 20 times

Summary

This Phase 3 trial tests a device called SonoCloud-9, which uses ultrasound to temporarily open the blood-brain barrier, allowing more carboplatin chemotherapy to reach glioblastoma tumors that have returned after initial treatment. About 560 participants will be randomly assigned to receive either the SonoCloud-9 with carboplatin or standard chemotherapy (lomustine or temozolomide). The main goal is to see if the combination improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Carboplatin (chemotherapy) delivered with SonoCloud-9 ultrasound device to open the blood-brain barrier
What this could lead to: If successful, this could offer a new treatment option for recurrent glioblastoma by allowing more chemotherapy to reach the brain tumor, potentially improving survival.
What could go wrong: This is a Phase 3 trial, but the approach is novel and may not improve outcomes over standard care. Risks include side effects from chemotherapy and potential complications from the implanted ultrasound device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 560 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically proven glioblastoma (WHO criteria 2021), absence of IDH mutation demonstrated by negative IDH1 R132H staining on Immunohistochemistry. 2. Patient must have received prior first line therapy that must have contained both: 1. Prior surgery or biopsy and standard fractionated radiotherapy (1.8-2 Gy/fraction, ≥56 Gy\<66 Gy) or hypofractionated radiotherapy (15 x 2.66 Gy or similar regimen) 2. One line of maintenance chemotherapy and/or immune- or biological therapy, (with or without Tumor-Treating Fields) 3. First, unequivocal disease progression with 1. measurable tumor (\>100 mm2 or 1 cm3, based on RANO criteria) documented (e.g., increase of 25% in tumor diameter) on MRI and, 2. interval of a minimum of 12 weeks since the completion of prior radiotherapy, unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling 4. Patient is a candidate for craniotomy and at least 50% resection of enhancing region 5. Maximal enhancing tumor diameter prior to inclusion ≤ 5 (+7%) cm on T1w on MRI performed within 14 days prior to inclusion§. (In case of planned lobectomy, post operative peritumoral brain or residual size ≤5 cm) 6. WHO performance status ≤ 2 (equivalent to Karnofsky Performance Status (KPS) ≥ 70) 7. Age ≥ 18 years 8. Participant must be recovered from acute toxic effects (≤ grade 2) of all prior anticancer therapy. Interval since last therapy to presumed date of surgery of at least: 1. ≥ 4 weeks or 5 half-lives (whichever is shorter) for * 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.: 1. Hemoglobin ≥ 10 g/dL, platelets ≥ 100,000/mm3, neutrophils ≥ 1500/mm3. 2. Liver function test with ≤ grade 1 alterations, except if due to antiepileptic drug therapy or isolated increased bilirubin due to Gilbert syndrome 3. Estimated glomerular filtration rate (eGFR) of at least 60 mL/min/m2 using Appendix 12.4 formula 4. AST(SGOT)/ALT(SPGT) ≤ 3 X institutional ULN (upper Limit of Normal) 10. Patient able to understand clinical trial information and willing to provide signed and informed consent 11. Patient of childbearing potential must have a negative pregnancy test within 14 days prior to inclusion§ and must agree to use a medically-acceptable method of birth control during the treatment period and, if randomized in the experimental arm, for at least 1 month after the last cycle of carboplatin 12. A male patient must agree to use condoms during the treatment period and, if randomized in the experimental arm, for at least 3 months after the last cycle of carboplatin; the patient must also refrain from donating sperm during this period. 13. Patient must be a beneficiary of a health plan that covers routine patient care costs. Patient must be a beneficiary of or affiliated with a social security scheme (according to country-specific requirements) (§) These exam/lab tests could be (re)evaluated before randomization if the corresponding selection criteria could not be fully met at time of inclusion. If not met before randomization, the patient will be considered as screen failure. Non-Inclusion Criteria: 1. Multifocal enhancing tumor on T1w (unless all localized in a 5 cm diameter area) 2. Posterior fossa tumor 3. Known BRAF/ NTKR mutated patients 4. Patient at risk of surgery site infection (e.g., 2 or more previous craniotomies/neurosurgery within the last 3 months, poor skin condition, known impaired wound healing and/or previously infected surgical field, uncontrolled diabetes or any other condition that is of increased infectious risk in the opinion of the neurosurgeon) 5. Patient treated at high, stable -or average- dose of corticosteroids (≥ 6 mg/day dexamethasone or equivalent) in the 7 days prior to inclusion. Patients on dexamethasone for reasons other than mass effect may still be enrolled. 6. Contra-indication to carboplatin, CCNU or TMZ 7. Known history of hypersensitivity reactions to perflutren lipid microsphere components or to any of the inactive ingredients in ultrasound resonator 8. Patient has received bevacizumab for other reasons (such as tumor progression) than treating edema 9. Peripheral neuropathy or neuropathy ≥ grade 2 10. Uncontrolled epilepsy or evidence of intracranial pressure 11. Patient with known intracranial aneurism or having presented intra-tumor significant spontaneous hemorrhage 12. Patient with unremovable coils, clips, shunts, intravascular stents, and/or wafer, or reservoirs 13. Patient with medical need to be on continued anti-platelet aggregation therapy and/or anticoagulation. Patients for whom anticoagulation/platelet aggregation can be temporarily interrupted may be eligible after discussion and prior authorization by the sponsor. 14. Patient receiving enzyme-inducing antiepileptic drugs (namely phenytoin, carbamazepine and derivatives, phenobarbital), unless switched on another antiepileptic regimen 15. History of other malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix 16. Patient with known or suspected active or chronic infections 17. Patient with known significant cardiac disease, known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \> 90 mm Hg), uncontrolled systemic hypertension, or acute respiratory distress syndrome 18. Known sensitivity/allergy to gadolinium, or other intravascular contrast agents 19. Patient with impaired thermo-regulation or temperature sensation 20. Pregnant, or breastfeeding patient 21. Any other serious patient medical or psychological condition that may interfere with adequate and safe delivery of treatment and care (e.g., positive human immunodeficiency virus \[HIV\] status, potential blood-borne infections, malnutrition…), circumstance (e.g., sinus opening during surgery), psychological, morphological characteristics (e.g., skin characteristics, bone thickness), or any pre-existing comorbidities that in the investigator's opinion may prevent the implantation of the device, may impair the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical trial endpoints 22. Patients under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision Exclusion Criterion: Occurrence of any major medical illnesses or impairments that in the Investigator's opinion may hampered the ability of the patient to receive treatment with SonoCloud-9 or may be confounding for evaluation of the clinical endpoints.

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Conditions

The condition(s) this trial relates to.

glioblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GBM Glioblastoma Recurrent glioblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

52 sites in 11 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

Akademiska sjukhuset
RECRUITING

Uppsala, 75185, Sweden
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino
RECRUITING

Torino, 10126, Italy
CHU de Liège
RECRUITING

Liège, Belgium
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING

Lausanne, 1011, Switzerland
Charité Universitätsmedizin Berlin
RECRUITING

Berlin, 10117, Germany
Erasmus Medisch Centrum (Erasmus MC)
RECRUITING

Rotterdam, Netherlands
Haaglanden Medisch Centrum
RECRUITING

The Hague, 2263, Netherlands
Hospital Clinic de Barcelona
RECRUITING

Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, Spain
Hospital Universitario HM Sanchinarro
RECRUITING

Madrid, 28050, Spain
Hospital Universitario Virgen del Rocío
RECRUITING

Seville, 41013, Spain
Hôpital Foch
RECRUITING

Suresnes, 92150, France
Hôpital Neurologique Pierre Wertheimer
RECRUITING

Bron, France
Hôpital de La Timone
RECRUITING

Marseille, France
Hôpital de la Pitié-Salpêtrière
RECRUITING

Paris, France
IFO - Istituto Nazionale Tumori Regina Elena
RECRUITING

Roma, Italy
Indiana University Health
RECRUITING

Indianapolis, Indiana, 46202, United States
Inselspital Bern
RECRUITING

Bern, 3010, Switzerland
Irccs Istituto Clinico Humanitas
RECRUITING

Rozzano, 20089, Italy
Istituto Oncologico Veneto
RECRUITING

Padua, Italy
John Hopkins University
RECRUITING

Baltimore, Maryland, 21287, United States
Kaiser Permanente
NOT_YET_RECRUITING

Los Angeles, California, 90027, United States
Klinikum Chemnitz gGmbH
RECRUITING

Chemnitz, 09113, Germany
Lennox Hill Hospital
RECRUITING

New York, New York, 10075, United States
Mayo Clinic Arizona
RECRUITING

Phoenix, Arizona, 805054, United States
Mayo Clinic Rochester
ACTIVE_NOT_RECRUITING

Rochester, Minnesota, 55905, United States
Mayo Clinic of Jacksonville Florida
RECRUITING

Jacksonville, Florida, 32224, United States
Medizinische Universitaet Innsbruck
RECRUITING

Innsbruck, 6020, Austria
Miami Cancer Institute
RECRUITING

Miami, Florida, 33176, United States
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States
Neurochirurgie uniklinik Köln
RECRUITING

Cologne, Germany
Neurological Institute Brain Tumor Centre Taussig Cancer Cente
RECRUITING

Cleveland, Ohio, 44106, United States
NewYork-Presbyterian / Columbia University Irving Medical Center
RECRUITING

New York, New York, 10032, United States

Contact Email: •••••@•••••
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
Odense University Hospital
RECRUITING

Odense, 5000, Denmark
Ospedale Bellaria
RECRUITING

Bologna, 40139, Italy
Ospedale Civile di Livorno
RECRUITING

Livorno, 57124, Italy
Penn State Health Milton S. Hershey Medical Center
ACTIVE_NOT_RECRUITING

Hershey, Pennsylvania, 17033, United States
Rigshospitalet
RECRUITING

Copenhagen, 2100, Denmark
Sahlgrenska University Hospital
RECRUITING

Gothenburg, 413 45, Sweden
Sutter Health - California Pacific Medical Center
RECRUITING

San Francisco, California, 94109, United States
UCHealth
RECRUITING

Aurora, Colorado, 80011, United States
UCLA
NOT_YET_RECRUITING

Los Angeles, California, 90095, United States
Universitair Ziekenhuis Brussel
RECRUITING

Brussels, Belgium
Universitair Ziekenhuis Leuven
RECRUITING

Leuven, Belgium
University Hospital Munster
RECRUITING

Münster, 48149, Germany
University of California, San Francisco
ACTIVE_NOT_RECRUITING

San Francisco, California, 94143, United States
University of North Carolina
RECRUITING

Chapel Hill, North Carolina, 27516, United States
University of Texas Houston Health Science Center
ACTIVE_NOT_RECRUITING

Houston, Texas, 77030, United States
University of Texas Southwestern Medical Center
RECRUITING

Dallas, Texas, 75390, United States
University of Utah, Hunstman Cancer Institute
RECRUITING

Salt Lake City, Utah, 84112, United States
Universitätsklinikum Carl Gustav Carus Dresden
RECRUITING

Dresden, 01307, Germany
Universitätsklinikum Essen Klinik für Neurologie
RECRUITING

Essen, 45147, Germany
Vall d'Hebron Institute of Oncology (VHIO)
RECRUITING

Barcelona, 08035, Spain
Weill Cornell Medicine
RECRUITING

New York, New York, 10021, United States
Winship Cancer Institute at Emory University
RECRUITING

Atlanta, Georgia, 30322, United States

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