How does the Sonobird trial work?
The objective of the SONOBIRD trial is to show that the association of carboplatin with the SonoCloud-9 will increase the efficacy of chemotherapy in patients with recurrent glioblastoma. To be able to compare effectiveness and safety of each treatment, patients taking part in this research will be randomized into two groups.
Treatment set-up
SonoCloud-9 implant placement
For the patients who will be randomized in the experimental group (EA), the surgeon will place the SonoCloud-9 implant in the thickness of the skull at the end of the resection surgery and close the wound.
For the patients who will be randomized in the control group (CA), the surgeon will close the wound without implanting the SonoCloud-9 device.
Starting the chemotherapy
After a few days to allow for recovery from surgery, the chemotherapy will start. The patients in the experimental arm group will receive an infusion of carboplatin administered intravenously. At the end of the infusion, the SonoCloud-9 implant will be connected to the generator using the transdermal needle that goes through the skin of the scalp into the implant, allowing the implant to emit ultrasound (without connection to the generator, the implant is completely inactive). Simultaneously, the microbubbles, or ‘ultrasound resonator’ will be administered into a vein. After few minutes of ultrasound emission, the needle will be disconnected from the implant. This procedure will be repeated every 3 weeks for up to 7 cycles at the hospital.
The patients in the control group will receive lomustine (oral capsules) or temozolomide (oral capsules) depending on what the neurooncologist thinks to be the most appropriate drug according to the patients’ disease history. Chemotherapy intake will be repeated every 6 weeks for up to 4 cycles (Lomustine) or every 4 weeks for up to 6 cycles (Temozolomide).
Treatment monitoring
Participants of both groups will be closely monitored during their treatment (up to 7 months). Patient whose disease progresses while receiving treatment or after treatment will be treated according to local standards at the doctor’s discretion. Scans and medical follow up will be performed according to the institution’s standard practices. The participants may be followed for up to 48 months.
What is a clinical trial?
Clinical trials are research studies that investigate new tests and treatments (including drugs, biologics, surgical procedures, radiological procedures, devices, etc.) and evaluate their effects on human health. Clinical trials are conducted by a sponsor in accordance with Good Clinical Practice (GCP) guidelines.
Clinical trials, carefully designed with physicians, must be approved by regulatory authorities and ethics committees before they can begin. Patient participation in clinical trials is voluntary. Clinical trials usually involve participants from several medical or research institutions, and often from several countries.
Carthera, as sponsor, conducts each trial according to a protocol. The protocol, or investigation plan, defines the types of patients who can take part in the trial (eligibility criteria), the schedule of tests and procedures, the products studied and their dosage, as well as the nature and duration of follow-up.
It also describes the type of information that will be collected and how it will be analyzed to achieve the trial’s objectives. The results are communicated to the regulatory authorities to obtain marketing authorization at the end of full development, and to payers to obtain reimbursement.
