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Chemotherapy
Ultrasound-Assisted Chemotherapy for Glioblastoma (SONOBIRD Trial)
Phase 3
Recruiting
Research Sponsored by CarThera
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
SONOBIRD Trial Summary
This trial will test a device using ultrasound to open the blood-brain barrier to allow more drugs to reach brain tumours, and assess the increased efficacy of carboplatin in treating recurrent glioblastoma.
Who is the study for?
Adults over 18 with confirmed glioblastoma who've had prior surgery, radiotherapy, and chemotherapy can join. They must have a tumor that's grown after treatment but is less than 5 cm wide. Participants need good organ function, no severe allergies to trial drugs or device components, and not be on certain medications like anti-platelet drugs.Check my eligibility
What is being tested?
The trial tests if using SonoCloud-9 (SC9), an ultrasound device designed to temporarily open the blood-brain barrier (BBB), increases the effectiveness of Carboplatin in treating recurrent glioblastoma compared to standard chemotherapies Lomustine or Temozolomide alone.See study design
What are the potential side effects?
Possible side effects include reactions related to opening the BBB such as temporary inflammation or discomfort at the site of ultrasound application. Carboplatin may cause nausea, fatigue, low blood counts increasing infection risk, and nerve damage.
SONOBIRD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Overall survival at 12 months (OS12)
Overall survival at 18 months (OS18)
Progression Free Survival (PFS)
+2 moreOther outcome measures
Safety and Tolerability
SONOBIRD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm: SonoCloud-9 Ultrasound + CarboplatinExperimental Treatment2 Interventions
The SonoCloud-9 (SC9) device will be implanted in the skull bone window upon completion of tumor resection and routine craniotomy. Carboplatin (CBDCA) will be administered intravenously prior to sonication. The CBDCA/SC9 treatment will be repeated every 3 weeks (depending on patient's tolerability) until disease progression or as clinically indicated. Administration of up to 7 cycles is planned.
Group II: Control Arm: SoC single agent chemotherapy TMZ or CCNUActive Control2 Interventions
Standard of Care (SoC) treatment with either temozolomide (TMZ) or lomustine (CCNU).
Standard TMZ chemotherapy as a single oral dose every 4 weeks for up to 6 cycles.
Standard CCNU chemotherapy as a single oral dose every 6 weeks for up to 4 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
CarTheraLead Sponsor
5 Previous Clinical Trials
154 Total Patients Enrolled
3 Trials studying Glioblastoma
120 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at risk of getting an infection at my surgery site.I do not have uncontrolled seizures or signs of high pressure inside my skull.I do not have any serious health or mental conditions that could affect my treatment.I cannot take carboplatin, CCNU, or TMZ due to adverse reactions.I agree to use condoms and not donate sperm during treatment.My cancer has a BRAF or NTRK mutation.I am taking medication for epilepsy that increases enzyme activity.My cancer has visibly worsened on an MRI within the last 2 weeks, and it's been at least 3 months since I finished radiotherapy.I've been on a high, stable dose of corticosteroids for the last week.I have or might have an ongoing infection.I do not have major illnesses that could affect my treatment or its assessment.I have a serious heart condition, very high blood pressure, or severe lung problems.I am eligible for brain surgery with significant tumor removal.I need to keep taking my blood thinning medication.I have been treated with bevacizumab for reasons other than swelling.My brain tumor is confirmed as glioblastoma without IDH mutation.I have recovered from the side effects of my previous cancer treatments.I am mostly able to care for myself and carry out daily activities.I am 18 years old or older.I do not have severe nerve pain or damage.My tumor is located in the back part of my brain.My health plan covers routine care costs and I am covered by or affiliated with social security.I've had surgery or a biopsy, radiotherapy, and maintenance therapy for my cancer.I have trouble feeling temperature changes or regulating my body temperature.I am not under legal supervision or deprived of liberty.I have a known brain aneurysm or significant bleeding within a tumor.I haven't had any other cancer than the current one in the last 3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin
- Group 2: Control Arm: SoC single agent chemotherapy TMZ or CCNU
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin obtained governmental validation?
"We rate the safety of Experimental Arm: SonoCloud-9 Ultrasound + Carboplatin as a 3, based on its Phase 3 status. It has been studied enough to demonstrate both effectiveness and multiple layers of security."
Answered by AI
Are there multiple locations in Canada where this medical experiment is being conducted?
"At this time, 8 distinct medical sites are enrolling participants for the trial. These locations include Leuven, Bron and Marseille as well as 5 other cities - it is advised to select a location nearby you in order to avoid extensive travelling should you decide to join."
Answered by AI
Are there still opportunities for participants to join this experiment?
"The records on clinicaltrials.gov show that this particular trial is not presently seeking participants; it was initially posted on November 5th 2023 and last updated June 5th of the same year. Although this study has finished recruiting, there are 468 other active studies currently employing new patients."
Answered by AI
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