Glioblastoma (GBM) is the most common and aggressive form of primary brain cancer. The prognosis is currently very poor, with a survival of about 15 months with current therapies. Even with intensive treatments combining surgery, radiotherapy and chemotherapy, the prognosis of glioma patients remains poor.
The objective of the phase II clinical trial, SonoFIRST, is to improve the survival of newly diagnosed glioblastoma patients with the therapeutic ultrasound device, sonocloud-9 (SC9). In the brain, the presence of the blood-brain barrier (BBB) limits the uptake of therapeutic agents. To address the problems of BBB passage, Professor Alexandre Carpentier and his teams have developed an ultrasound medical device (the SonoCloud). This highly innovative technique temporarily permeabilises the BBB, increasing the delivery of drugs to the brain fivefold. The Sonocloud, a low-intensity pulsed ultrasound device developed by CarThera, is one of the major innovations in this field as shown by the encouraging results obtained in studies in GBM with recurrence (Carpentier et al., Science Trans Med, 2016; Idbaih et al. Clin Cancer Res, 2019).
SonoFIRST is the first European clinical trial with the device implanted in patients diagnosed with de-novo GBM, and is supported by the European EIT Health programme with an allocation of €2.9 million. Seven “centres of excellence” are participating in this trial:
- five sites in France: Hôpital de la Pitié-Salpêtrière (AP-HP) in Paris, CHU in Angers, Hôpital Pierre Wertheimer in Lyon, Hôpital Pellegrin in Bordeaux, Hôpital de la Timone in Marseille
- one site in Belgium: Katholieke Universiteit Leuven
- one site in Switzerland: Centre hospitalier universitaire vaudois (CHUV) in Lausanne
At each site, expert clinical departments in oncology, neuro-oncology, neuroradiology, neurosurgery and histopathology will be involved.
The project will last for three years during which it is planned to include 60 European patients. Patient recruitment at the Pitié-Salpêtrière Hospital AP-HP will begin in September 2020. The opening of the other six centres will follow and will take place at the end of 2020.
The SonoFIRST project is led by Professor Alexandre Carpentier, MD, PhD, neurosurgeon and head of the neurosurgery department at the Pitié-Salpêtrière Sorbonne-University Hospital, as scientific director, and by Professor Ahmed Idbaih, MD, PhD, neuro-oncologist in the Neuro-Oncology 2 department at the Pitié-Salpêtrière Sorbonne-University Hospital, as coordinating investigator. AP-HP (coordination and promotion) is one of the four consortium partners involved in this project, together with Sorbonne-Université (valorisation), CarThera (production) and Katholieke Universiteit Leuven.
The highly innovative SC9 device offers the prospect of improving the survival of 160,000 brain tumour patients per year in Europe and the United States and its application could be extended to other brain diseases.
For more information: https://carthera.eu/fr/sono-cloud-2/for-a-selective-brain-therapy/