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

PHASE3RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 8, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions
Glioblastoma MultiformeGlioblastomaGlioblastoma Multiforme, AdultGliomaBrain TumorBrain Tumor, RecurrentNeoplasmsNeoplasms, Nerve Tissue
Interventions
DRUG

Bevacizumab

An anti-angiogenic agent to block tumor growth

DRUG

Microbubble

Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble

DEVICE

Low-Intensity Focused Ultrasound

Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble

Trial Locations (2)

10048

RECRUITING

National Taiwan University Hospital, Taipei

33305

RECRUITING

Linkou Chang Gung Memorial Hospital, Taoyuan District

Sponsors
All Listed Sponsors
lead

NaviFUS Corporation

INDUSTRY