RecruitingPhase 3NCT06496971

A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients

A Prospective, Randomized, Standard of Care Controlled, Parallel, Open-Label, Multicenter Pivotal Study to Evaluate the Efficacy and Safety of Avastin® in Combination With NaviFUS System Compared With Avastin® Alone for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

Sponsor

NaviFUS Corporation

Enrollment

32 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

Neoplasms Brain Tumor Glioblastoma Glioma Glioblastoma Multiforme Brain Tumor, Recurrent Neoplasms, Nerve Tissue Glioblastoma Multiforme, Adult

Summary

This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using focused ultrasound with tiny bubbles (to temporarily open the blood-brain barrier) alongside the drug bevacizumab can help treat recurrent glioblastoma — the most aggressive type of brain cancer — more effectively than bevacizumab alone. **You may be eligible if...** - You are 18 or older with a confirmed glioblastoma diagnosis that has come back after radiation therapy and temozolomide chemotherapy - Your cancer recurrence is confirmed by MRI scan - Your general health and body mass index (BMI ≥ 17) are sufficient for the procedure - You have recovered adequately from any prior surgery for recurrence **You may NOT be eligible if...** - You have not yet had standard treatment (radiation + temozolomide) - You have serious heart conditions, implanted devices (like pacemakers), or other conditions that make focused ultrasound unsafe - You have active bleeding in the brain or serious blood clotting problems - You have already received bevacizumab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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