Combination of Neuronavigation-Guided Focused Ultrasound and Bevacizumab for Patients With Recurrent Glioblastoma: A Pilot Study.
Ko-Ting Chen, Hong-Chieh Tsai, Chiung-Yin Huang...
https://pubmed.ncbi.nlm.nih.gov/41283685Actively Recruiting
Phase 3
Age: 18Years - 80Years
All Genders
ID06496971
A Prospective, Randomized Study to Evaluate Bevacizumab With or Without NaviFUS System Focused Ultrasound for Recurrent Glioblastoma Multiforme
Led by NaviFUS Corporation · Updated on 2026-04-09
32
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of Bevacizumab (BEV) with or without microbubble-mediated focused ultrasound (FUS) using the NaviFUS System in patients with recurrent glioblastoma multiforme (rGBM). This pivotal, randomized, open-label study compares standard care BEV alone to BEV combined with FUS in patients who have previously undergone surgery, radiotherapy, and chemotherapy with temozolomide. BEV is considered the best current treatment choice for these patients after prior therapies. Participants will be randomly assigned to one of two groups. One group will receive BEV alone via intravenous infusion at a dose of 10 mg/kg over 30-90 minutes every two weeks. The other group will receive the same BEV treatment followed by administration of microbubbles (SonoVue®) at 0.1 mL/kg and focused ultrasound exposure controlled by the NaviFUS System. Treatments will continue every two weeks for up to 34 weeks or until disease progression, intolerable side effects, non-compliance, or withdrawal. During the study, participants will be monitored through regular assessments including MRI scans, quality of life questionnaires, cognitive tests (Mini-Mental State Examination), and evaluation of corticosteroid use and adverse events. The primary outcome is progression-free survival at six months. Secondary outcomes include survival rates up to two years, tumor response, local disease control, and performance status. The total study participation can last up to 36 months with ongoing safety and efficacy monitoring.
CONDITIONS
Brief 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
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years or older at enrollment
- Body mass index 17 kg/m2 or higher
- Confirmed recurrent glioblastoma by MRI after prior radiotherapy and temozolomide chemotherapy
- Completed surgery for recurrence and recovered prior to enrollment
- At least 80% resection of enhancing tumor or residual tumor 20 cm3 or less
- Stable or decreasing corticosteroid dose for at least 1 week before treatment
- Minimum intervals since last procedures: 4 weeks for major surgery, 1 week for minor procedures
- Recovery from prior therapies: 4 weeks from investigational drug/device or chemotherapy, 6 weeks from nitrosourea chemotherapy, 12 weeks from radiotherapy
- Life expectancy of at least 12 weeks
- Karnofsky Performance Status 70 or higher
- Adequate blood, kidney, liver, and coagulation function within 2 weeks before treatment
- FUS exposure region located at least 30 mm beneath skull bone
- Negative pregnancy test for females of childbearing potential and use of contraception
- Ability to have IV line for Bevacizumab and hair shaved if in treatment group
- Ability and willingness to provide informed consent and comply with study procedures
You will not qualify if you...
- Multifocal enhancing tumors on imaging
- Prior treatment with anti-angiogenic therapy or VEGF inhibitors
- Previous Carmustine wafer implantation
- Current or prior tumor treating fields therapy
- Significant cardiovascular disease including recent heart failure, unstable angina, or recent heart attack
- Stroke (except transient ischemic attack) within 6 months
- Implanted electronic devices incompatible with MRI
- Uncontrolled hypertension above specified limits
- Recent thrombotic or hemorrhagic events or bleeding disorders
- Unstable pulmonary disease or recent respiratory illness requiring hospitalization
- Psychiatric or social issues limiting study compliance
- Known HIV infection
- Active bacterial or fungal infection requiring IV antibiotics
- Recent active gastroduodenal ulcers or related conditions
- Use of anticoagulants or antiplatelets within 1 week before treatment
- Known allergies to study drugs or contrast agents
- Pregnant or breastfeeding women
- Recreational drug use or history of addiction
- Other severe uncontrolled medical conditions
- Any condition increasing risk or affecting study evaluation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 34 weeks or until disease progression, intolerable toxicity, non-compliance, or withdrawal
Participants receive Bevacizumab through intravenous infusion every 2 weeks. Those in the experimental group also receive microbubble-mediated focused ultrasound treatment after Bevacizumab infusion.
Visits every 2 weeks for treatment administration
Follow-up
Duration - Up to 36 months
Participants are monitored for survival, disease progression, and treatment-related outcomes after treatment ends.
Additional visits may occur for monitoring during this period
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
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Research Team
S
Sheang-Tze Fung, Ph.D.
A
Arthur Lung, Ph.D.
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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Published Research Related To This Trial
Blood-brain barrier disruption with focused ultrasound enhances delivery of chemotherapeutic drugs for glioblastoma treatment.
Hao-Li Liu, Mu-Yi Hua, Pin-Yuan Chen...
https://pubmed.ncbi.nlm.nih.gov/20413754Focused ultrasound-induced blood-brain barrier opening to enhance temozolomide delivery for glioblastoma treatment: a preclinical study.
Kuo-Chen Wei, Po-Chun Chu, Hay-Yan Jack Wang...
https://pubmed.ncbi.nlm.nih.gov/23527068Focused Ultrasound Enhances Central Nervous System Delivery of Bevacizumab for Malignant Glioma Treatment.
Hao-Li Liu, Po-Hung Hsu, Chung-Yin Lin...
https://pubmed.ncbi.nlm.nih.gov/27192459Neuronavigation-guided focused ultrasound (NaviFUS) for transcranial blood-brain barrier opening in recurrent glioblastoma patients: clinical trial protocol.
Ko-Ting Chen, Ya-Jui Lin, Wen-Yen Chai...
https://pubmed.ncbi.nlm.nih.gov/32617293Neuronavigation-guided focused ultrasound for transcranial blood-brain barrier opening and immunostimulation in brain tumors.
Ko-Ting Chen, Wen-Yen Chai, Ya-Jui Lin...
https://pubmed.ncbi.nlm.nih.gov/33547073