๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-17

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM (NCT05902169)

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.

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: CarThera

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Arizona โ€” Phoenix, Arizona

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (55 Sites)

Showing the first 25 of 55 sites.

  • Mayo Clinic Arizona โ€” Phoenix, Arizona
  • Kaiser Permanente โ€” Los Angeles, California
  • UCLA โ€” Los Angeles, California
  • Sutter Health - California Pacific Medical Center โ€” San Francisco, California
  • University of California, San Francisco โ€” San Francisco, California
  • UCHealth โ€” Aurora, Colorado
  • Mayo Clinic of Jacksonville Florida โ€” Jacksonville, Florida
  • Miami Cancer Institute โ€” Miami, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Winship Cancer Institute at Emory University โ€” Atlanta, Georgia
  • Northwestern University โ€” Chicago, Illinois
  • Indiana University Health โ€” Indianapolis, Indiana
  • John Hopkins University โ€” Baltimore, Maryland
  • Mayo Clinic Rochester โ€” Rochester, Minnesota
  • Weill Cornell Medicine โ€” New York, New York
  • NewYork-Presbyterian / Columbia University Irving Medical Center โ€” New York, New York
  • Lennox Hill Hospital โ€” New York, New York
  • University of North Carolina โ€” Chapel Hill, North Carolina
  • Neurological Institute Brain Tumor Centre Taussig Cancer Cente โ€” Cleveland, Ohio
  • Penn State Health Milton S. Hershey Medical Center โ€” Hershey, Pennsylvania
  • University of Texas Southwestern Medical Center โ€” Dallas, Texas
  • University of Texas Houston Health Science Center โ€” Houston, Texas
  • University of Utah, Hunstman Cancer Institute โ€” Salt Lake City, Utah
  • Medizinische Universitaet Innsbruck โ€” Innsbruck,
  • Universitair Ziekenhuis Brussel โ€” Brussels,

๐Ÿ“ž Contact the Study Coordinator

Phone: +33 472 626 268

Email: contact@carthera.eu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Glioblastoma clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—