What is Bevacizumab studying for recurrent glioblastoma?

Bevacizumab is being studied to see if adding microbubble-mediated focused ultrasound improves treatment for recurrent glioblastoma. This trial compares standard Bevacizumab treatment alone to Bevacizumab with the NaviFUS System to evaluate effects on tumor control and patient safety.

Who may be eligible for this recurrent glioblastoma clinical trial?

Adults aged 18 to 80 years with confirmed recurrent glioblastoma after prior radiotherapy and chemotherapy may be eligible. Both males and females can participate, provided they meet health and treatment history criteria such as no prior anti-angiogenic therapy and adequate organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this recurrent glioblastoma clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years - 80Years

All Genders

ID06496971

Study Comparing Avastin Bevacizumab With or Without NaviFUS Ultrasound System in Adults With Recurrent Glioblastoma Multiforme

Led by NaviFUS Corporation · Updated on 2026-04-09

Participants Needed

Research Sites

12 weeks

Total Duration

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 mgkg 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 mLkg 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

Research Team

Sheang-Tze Fung, Ph.D.

Arthur Lung, Ph.D.

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