FDA Approves New Focused Ultrasound Clinical Trial to Treat Deadly Brain Tumors


Cathera Image smFrench manufacturer, CarThera, recently announced that the FDA has granted approval to begin a US clinical trial of their SonoCloud-9 ultrasound device in patients with recurrent glioblastoma (GBM).

The trial will measure the safety, tolerance, and efficacy of repeatedly opening the blood-brain barrier (BBB) in 27 patients before infusion of the chemotherapy drug, carboplatin. Two French sites are already treating patients as part of this trial, and with the FDA’s positive ruling, MD Anderson Cancer Center in Houston and Northwestern Memorial Hospital in Chicago will soon begin enrollment.

CarThera’s trial is one of many investigating the feasibility of disrupting the BBB using ultrasound. However, SonoCloud is unique in that it is an implant inserted into the skull, which is only activated prior to chemotherapy. Low-intensity ultrasound is used to open the BBB in the region of the tumor to deliver chemotherapy in higher concentrations.

This trial will build upon an earlier trial in France of CarThera’s first generation device, the SonoCloud-1. According to the company, the SonoCloud-9 “brings a nine-fold increase in coverage of the tumor and surrounding infiltrative areas.”

“We are excited to initiate this clinical trial in the US to evaluate the potential of the SonoCloud-9 device for glioblastoma patients,” said Professor Alexandre Carpentier, inventor of the technology and founder of CarThera. “Our first clinical study confirmed the safety and feasibility of this solution. We believe it represents a major step forward in the treatment of GBM.”

Looking forward, CarThera expects a pivotal trial for GBM to begin in late 2020 in Europe and the US. The company is also exploring use of the technology in patients with Alzheimer’s disease and brain metastases.

“Therapeutic ultrasound research has significantly increased in importance over the last decade,” said Michael Canney, scientific director at CarThera. “We are delighted that we can now introduce our ultrasound technology to US clinical and research centers. We believe that this is a significant step in developing this technology for use with a wide range of therapies for treatment of brain diseases.” 

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