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

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.

Trial Details

NCT ID
NCT06496971
Phase
PHASE3
Sponsor
NaviFUS Corporation
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Bevacizumab
  • Microbubble
  • Low-Intensity Focused Ultrasound
Locations (sample)
  • Taipei, Taiwan|25.05306,121.52639
  • Taoyuan, Taiwan|24.99368,121.29696

Key Eligibility Criteria

  • Male or female patients ≥ 18 years of age at the time of study enrollment.
  • Body mass index (BMI) ≥ 17 kg/m2.
  • Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (C…
  • Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study …

For full eligibility, visit ClinicalTrials.gov.

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