SONOBIRD Study Treatment Groups
Your Study Treatment Group Assignment
You will be randomly assigned to 1 of 2 study treatment arms. You will receive either:
- SonoCloud-9 + carboplatin chemotherapy infusions or
- Standard of care chemotherapy (lomustine or temozolomide)
There is an equal chance of receiving either study treatment.
Your Tumor Removal Surgery
Prior to any study treatment, you will undergo tumor resection (removal). A study-appointed neurosurgeon will perform the resection. The study doctor/staff will talk with you more about this.
If you are in the SonoCloud-9 study treatment arm, you will have the device implanted at the end of the resection. A study-appointed neurosurgeon will also implant the SonoCloud-9 device.
You will be given time to recover from surgery. Typically, study treatment will begin about 2-3 weeks after your tumor resection.
Your Study Treatment
If you’re receiving SonoCloud-9 + carboplatin chemotherapy study treatment:
- You are given an infusion of carboplatin
- SonoCloud-9 is connected to an external generator
- The generator activates SonoCloud-9, which then emits ultrasound waves into your brain for 4 minutes
- After 4 minutes, SonoCloud-9 is disconnected from the generator, making the implant inactive
- This procedure is repeated every 3 weeks for up to 7 cycles
If you’re receiving standard of care chemotherapy study treatment (you will receive only 1 of the following):
- Lomustine is given as a single dose every 6 weeks for up to 4 cycles
- Temozolomide doses are given every 4 weeks for up to 6 cycles
Once study treatment is completed, follow-up will continue until the study ends.
Participating in this study will not lead to any additional costs to you or your health insurance. You and your insurance company will only be charged for the healthcare services that are a part of your routine care. The study doctor/staff will talk with you more about your health insurance plan and what it will cover in this study.