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NCT06496971 · ClinicalTrials.gov record · last posted 2026-04-09

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

StatusRecruiting
PhasePhase 3
Started2024-11-08
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Amendment record 3 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 3 times since 2024-07-10; most recent amendment 2026-04-06. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-11-12
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT06496971
Lead Sponsor NaviFUS Corporation
Conditions Glioblastoma Multiforme, Glioblastoma, Glioblastoma Multiforme, Adult, Glioma, Brain Tumor, Brain Tumor, Recurrent, Neoplasms, Neoplasms, Nerve Tissue
Enrollment 32 participants
Start Date 2024-11-08
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-09