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

ClinicalTrials.gov ID: NCT05902169

Public ClinicalTrials.gov record NCT05902169. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Oct 19, 2026, 11:14 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05902169
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: CarThera; Industry
Enrollment: 560 participants

Conditions and interventions

Conditions

Interventions

Device · Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 29, 2024 (Actual)
Primary completion: Jan 28, 2028 (Estimated)
Completion: Jun 30, 2028 (Estimated)
Last update posted: Oct 5, 2026

2024 – 2028

United States locations

U.S. sites: 23
U.S. states: 15
U.S. cities: 19

Facility	City	State	ZIP	Site status
Mayo Clinic Arizona	Phoenix	Arizona	805054	Recruiting
Kaiser Permanente	Los Angeles	California	90027	Not yet recruiting
UCLA	Los Angeles	California	90095	Not yet recruiting
Sutter Health - California Pacific Medical Center	San Francisco	California	94109	Recruiting
University of California, San Francisco	San Francisco	California	94143	Recruiting
UCHealth	Aurora	Colorado	80011	Recruiting
Mayo Clinic of Jacksonville Florida	Jacksonville	Florida	32224	Recruiting
Miami Cancer Institute	Miami	Florida	33176	Recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
Winship Cancer Institute at Emory University	Atlanta	Georgia	30322	Recruiting
Northwestern University	Chicago	Illinois	60611	Recruiting
Indiana University Health	Indianapolis	Indiana	46202	Recruiting
John Hopkins University	Baltimore	Maryland	21287	Recruiting
Mayo Clinic Rochester	Rochester	Minnesota	55905	Active, not recruiting
Weill Cornell Medicine	New York	New York	10021	Recruiting
NewYork-Presbyterian / Columbia University Irving Medical Center	New York	New York	10032	Recruiting
Lennox Hill Hospital	New York	New York	10075	Recruiting
University of North Carolina	Chapel Hill	North Carolina	27516	Recruiting
Neurological Institute Brain Tumor Centre Taussig Cancer Cente	Cleveland	Ohio	44106	Recruiting
Penn State Health Milton S. Hershey Medical Center	Hershey	Pennsylvania	17033	Recruiting
University of Texas Southwestern Medical Center	Dallas	Texas	75390	Recruiting
University of Texas Houston Health Science Center	Houston	Texas	77030	Recruiting
University of Utah, Hunstman Cancer Institute	Salt Lake City	Utah	84112	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05902169, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 5, 2026 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05902169 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →