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NCT05902169 · ClinicalTrials.gov registry record · Phase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
A Phase 3 study of Glioblastoma and Recurrent Glioblastoma, sponsored by CarThera.
- Active
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
- 20
- Study locations
NCT05902169 is a Phase 3 study of Glioblastoma and Recurrent Glioblastoma that is active but no longer recruiting, run by CarThera. The registered enrollment target is 560 participants, above the 106-participant average among 199 other Glioblastoma trials with a reported enrollment target (428% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT05902169, a Phase 3 study of Glioblastoma and Recurrent Glioblastoma, is active but no longer recruiting, sponsored by CarThera.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 560 participants
- Enrollment target
- 20
- Study locations
Study Summary
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 Studied
Interventions
- DRUG Carboplatin
- DRUG Temozolomide
- DRUG Lomustine
- DEVICE SonoCloud-9 (SC9)
Study Locations (20)
Florida
- Mayo Clinic of Jacksonville Florida - Jacksonville
- Miami Cancer Institute - Miami
- Moffitt Cancer Center - Tampa
New York
- Weill Cornell Medicine - New York
- NewYork-Presbyterian / Columbia University Irving Medical Center - New York
- Lennox Hill Hospital - New York
Texas
- University of Texas Southwestern Medical Center - Dallas
- University of Texas Houston Health Science Center - Houston
Arizona
- Mayo Clinic Arizona - Phoenix
California
- University of California, San Francisco - San Francisco
Colorado
- UCHealth - Aurora
Georgia
- Winship Cancer Institute at Emory University - Atlanta
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2024-01-29 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05902169
The ClinicalTrials.gov registry entry for NCT05902169 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 106-participant average among 199 other Glioblastoma trials with a reported enrollment target (428% higher). The listed sponsor is CarThera, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT05902169 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT05902169 about?
NCT05902169 is a clinical study titled "Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM". 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...
What is the current status of trial NCT05902169?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 2024-01-29. Estimated completion is 2028-06-30.
What conditions does trial NCT05902169 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma, GBM.
What interventions are being tested in trial NCT05902169?
The interventions under investigation include: Carboplatin (DRUG), Temozolomide (DRUG), Lomustine (DRUG), SonoCloud-9 (SC9) (DEVICE).
Who is sponsoring clinical trial NCT05902169?
This trial is sponsored by CarThera, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05902169 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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