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What is the SONOBIRD trial ?

SONOBIRD is an ongoing clinical trial* currently recruiting patients in Europe and the USA. It is evaluating the efficacy of using a combination of an implantable ultrasound device combined with chemotherapy comparison with standard-of care to treat recurrent glioblastoma.

What is the SonoCloud-9 ?

The SonoCloud-9 (SC9) uses ultrasound technology and is specially developed to transiently open the blood-brain barrier (BBB) in the area of and surrounding the tumor where most of therapeutic agents cannot readily penetrate.

The BBB is located at the level of blood vessels walls. It protects the brain from any toxic or inflammatory molecules, but it also prevents most drugs injected in the bloodstream from getting into brain tissue where the tumor is seated. The development of effective treatments against brain disease is thus limited due to the BBB properties.

The SC9 is composed of an implant, a transdermal needle connector, a generator and micro-bubbles. It has previously been evaluated in recurrent glioblastoma patients in Phase 1/2 trials.

More information on the SC9 device can be found here.

For illustration purpose only.

What are the objectives of the SONOBIRD trial ?

The objective of the SONOBIRD trial is to show that the association of carboplatin with the SonoCloud-9 will increase efficacy of the chemotherapy in patients with recurrent glioblastoma. The trial will evaluate the effectiveness of the treatment by SonoCloud-9 and carboplatin to prolong life in comparison with standard of care treatment (lomustine or temozolomide). The safety of the treatment by SonoCloud-9 and carboplatin and its effectiveness on tumor growth will also be assessed in comparison with standard of care by recording the patients’ disease status for the duration of the trial.

To be able to compare effectiveness and safety of each treatment, patients taking part in this research will be randomized into two groups, selected by chance. Participants in experimental group will be given SonoCloud-9 and carboplatin while participants in the standard of care group will be given the standard of care (lomustine or temozolomide).

Who can participate ?

This trial is open to adult patients at first recurrence of glioblastoma after initial therapy ,to whom doctors recommend a new partial or total tumor resection and chemotherapy.

Eligible patients should also:

present with a tumor maximum size of 5 centimeters in diameter
be recovered from side effects of all prior anticancer therapy
not have any other serious medical or psychological condition that may hamper safe delivery of treatment and care

More details can be found on clinicaltrials.gov and CTIS.

How is treatment performed ?

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 SC9 device.

After a few days to allow for surgery recovery, the chemotherapy will start. The patients in the group EA 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 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 hospital.

The patients in the control group will receive lomustine (oral capsules) or temozolomide (oral capsules) depending what the neurooncologist thinks to be the most appropriate according to patients’ disease history. Chemotherapies intake will be repeated every 6 weeks for up to 4 cycles (Lomustine) or every 4 weeks for up to 6 cycles (Temozolomide).

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.