Study of Bevacizumab with NaviFUS System for Recurrent Glioblastoma
This study is testing a new way to treat recurrent glioblastoma (a type of aggressive brain tumor) using a combination of treatments. It involves Bevacizumab, a drug that blocks tumor growth, and the NaviFUS System, which uses focused ultrasound and microbubbles (Lumason) to temporarily open the blood-brain barrier. Opening this barrier may help Bevacizumab reach the tumor more effectively. The study aims to see how safe and effective this combined treatment is for patients whose glioblastoma has returned after previous treatments. You may be able to join if you are at least 18 years old, have recurrent glioblastoma confirmed by MRI, and have received prior radiation and chemotherapy. The study plans to enroll up to 10 patients.
- Study design
- This is a small, single-arm study, meaning all participants will receive the same treatment. It is an open-label study, so both you and your doctors will know which treatments you are receiving.
- What's involved
- You will have a 2-week screening period. If eligible, you will receive Bevacizumab and the NaviFUS treatment every two weeks for up to 34 weeks, or until your disease progresses or side effects become too severe.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 52 weeks after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06329570
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)
Recruiting
PHASE1Ages 18+InterventionalTreatmentNaviFUS Corporation
~10 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:NaviFUS SystemLumasonBevacizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events (AEs)
Measured over up to 52 weeks
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
4 weeks out from invasive procedures (e.g., open biopsy, surgical resection, significant traumatic injury, or any other major surgery involving entry into a body cavity) and the patient must have recovered from the effects of surgery
1 week out from minor surgical procedures or core biopsies 8. Patients must have recovered from the toxic effects of prior therapy at the time of study enrollment as follows:
4 weeks out from any investigational drug or device
4 weeks out from chemotherapy
6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., Carmustine (BCNU))
12 weeks out from completion of radiotherapy 9. Patients should have a life expectancy ≥ 12 weeks. 10. Patients must have Karnofsky Performance Status (KPS) ≥ 70. 11. Adequate hematopoietic, renal, hepatic, and coagulation function, defined as:
Hemoglobin ≥ 10 g/dL
Platelets ≥ 100,000/mm3
Neutrophils ≥ 1,500/mm3
Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
Urine protein creatinine ratio (UPCR) \< 1 or urine dipstick for proteinuria ≤ 2+
Alanine aminotransferase (ALT) \< 3 × ULN
Aspartate aminotransferase (AST) \< 3 × ULN
Total bilirubin (TBL) \< 2 × ULN
Prothrombin time ≤ 1.5 x ULN
International Normalized Ratio (INR) \< 1.5 These tests must be conducted within 2 weeks prior to the planned first treatment. 12. The central of FUS exposure region is located close to the cortex, with a minimum distance of at least 30 mm beneath the skull bone. 13. Females of childbearing potential must have a negative pregnancy test documented within 2 weeks prior to first treatment. Females of childbearing potential and male patients with partners of childbearing potential must agree to adhere to an acceptable method of contraception (as outlined below) from prior to the first study treatment until at least 6 months after the completion of last treatment. Standard acceptable methods of contraception include the use of highly effective methods such as hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, spermicide, vasectomy, intrauterine device, or abstinence from sexual activity. 14. Patients are able and willing to have peripheral intravenous (IV) line placement of Bevacizumab and are able to have hair shaved (either whole head or in the region where the coupling membrane will touch) prior to FUS treatment. 15. Patients or their legal representatives are able to provide written informed consent for participation in the trial and patients are willing to comply the procedures (i.e., study-related assessments), instructions, and restrictions outlined in this study in the duration of the study.
Exclusion
New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment
Unstable angina pectoris
Medical history of myocardial infarction within 6 months prior to study enrollment
Cardiac shunt 6. Stroke (except for transient ischemic attack; TIA) within 6 months prior to study enrollment 7. Patients with implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator (RNS), deep brain stimulation (DBS), or other electronic devices implanted in the brain. 8. Patients with inadequately controlled hypertension, defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg while on medication, within 2 weeks prior to first treatment. 9. Patients with evidence of any thrombotic or hemorrhagic events, including but not limited to:
Inherited bleeding diathesis or significant coagulopathy with the risk of bleeding (i.e., in the absence of therapeutic anticoagulation).
History of pulmonary haemorrhage/haemoptysis ≥ grade 2 according to the CTCAE version 5.0 criteria within 1 month prior to study enrollment.
Arterial or venous thrombosis (e.g., pulmonary embolism) within 6 months prior to study enrollment. 10. Patients with unstable pulmonary disease or chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study enrollment. 11. Patients who have psychiatric illness/social situations that would limit compliance with study requirements. 12. Know HIV-positive patient, however, that HIV testing is not required for entry into this study. 13. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study enrollment. 14. History or evidence of active gastroduodenal ulcer, gastrointestinal perforations/fistula, or intra-abdominal abscess within 6 months prior to study enrollment. 15. Receiving anticoagulant (e.g., warfarin or LMW heparin) or antiplatelet (e.g., aspirin) therapy within 1 week prior to beginning treatment. 16. Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, Lumason® , Avastin® , or any of their components. 17. Pregnant (positive pregnancy test) or breast-feeding women. 18. Use of any recreational drugs or history of drug addiction. 19. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled epilepsy, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol. 20. Any other condition that, in the Investigator's discretion, might increase the risk to the patients or compromise the evaluation of the clinical trial endpoints.
What this trial measures
- Adverse Events (AEs)up to 52 weeks
The incidence and severity of AEs associated with FUS-MB+BEV treatment in patients with rGBM