Actively Recruiting
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
Led by NaviFUS Corporation · Updated on 2026-04-09
32
Participants Needed
2
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older at enrollment
- Body mass index of 17 kg/m2 or higher
- Histologically confirmed glioblastoma with clear evidence of recurrence by MRI after prior radiotherapy and temozolomide chemotherapy
- Patients may have had surgery for recurrence and must be recovered from surgery before enrollment
- Radiographic evidence of at least 80% tumor resection or residual tumor volume of 20 cm3 or less
- Stable or decreasing corticosteroid dose for at least one week before treatment
- At least 4 weeks since major surgery and recovered; at least 1 week since minor surgery or biopsy
- Recovery from prior therapy toxicities: 4 weeks from investigational drugs or chemotherapy, 6 weeks from nitrosourea chemotherapy, 12 weeks from radiotherapy
- Life expectancy of at least 12 weeks
- Karnofsky Performance Status of 70 or higher
- Adequate blood, kidney, liver, and coagulation function within 2 weeks before treatment
- FUS exposure region at least 30 mm beneath the skull
- Negative pregnancy test for females of childbearing potential within 2 weeks before treatment
- Agreement to use effective contraception during and for 6 months after treatment for patients and partners
- Ability and willingness for intravenous line placement and hair shaving if in treatment group
- Ability to provide informed consent and comply with study procedures
You will not qualify if you...
- Presence of multifocal enhancing brain tumors
- Prior treatment with anti-angiogenic drugs including Bevacizumab or VEGF inhibitors
- Previous Carmustine wafer implantation during re-operation
- Current or prior tumor treating fields therapy
- Significant cardiovascular disease including recent heart failure, unstable angina, recent heart attack, or cardiac shunt
- Stroke (except transient ischemic attack) within 6 months
- Implanted electronic devices or MRI contraindications
- Uncontrolled high blood pressure despite medication
- Recent or active bleeding or clotting disorders
- Unstable lung conditions or recent hospitalization for respiratory illness
- Psychiatric or social conditions limiting study compliance
- Known HIV infection
- Active bacterial or fungal infection requiring IV antibiotics
- Recent active gastrointestinal ulcers or abscesses
- Use of anticoagulants or antiplatelet drugs within 1 week prior to treatment
- Allergies to MRI or CT contrast agents, SonoVue, Bevacizumab, or components
- Pregnant or breastfeeding women
- Recreational drug use or history of drug addiction
- Other severe uncontrolled medical conditions posing safety risks
- Any other condition that may increase patient risk or affect study evaluation at investigator's discretion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
National Taiwan University Hospital
Taipei, Taiwan, 10048
Actively Recruiting
2
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
S
Sheang-Tze Fung, Ph.D.
CONTACT
A
Arthur Lung, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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