GBMNCT07274787
Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma
A study testing NaviFUS System, Lumason and Bevacizumab in people with GBM, run by University of Cincinnati at 1 site in United States.
Trial summary
This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GBM
- What is being tested?
- NaviFUS System, Lumason and Bevacizumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male/female patients ≥ 18 years of age.
- Histologically confirmed glioblastoma at original diagnosis, recurrent after prior radiotherapy and temozolomide chemotherapy.
- Must have measurable disease ≥ 10mm (according to RANO criteria) .
- Interval since completion of radiation treatment (including radiation at original diagnosis and/or radiation for recurrent disease) ≥ 12 weeks.
- If on steroids, must be on a stable dose for ≥ 7 days prior to study treatment.
- Body mass index (BMI) ≥17 kg / m2.
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- Minimum interval since last drug therapy:
- 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen), daily chemotherapy (e.g., metronomic temozolomide, cytoxan) or targeted therapies administered daily (e.g., gleevec, tarceva).
- 4 weeks since last cytotoxic therapy.
- 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., carmustine).
- Life expectancy ≥ 12 weeks.
- KPS Score > 60.
- Adequate hepatic, renal, coagulation, and hematopoietic function:
- Hemoglobin ≥ 8 g/dL.
- Platelets ≥ 100,000/mm3.
- Neutrophils ≥ 1,500/mm3.
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN).
- Urine protein creatinine (UPC) ratio < 1 or urine dipstick for proteinuria ≤ 2+.
- Alanine transaminase (ALT) < 3 x ULN.
- Aspartate transaminase (AST) < 3 x ULN.
- Prothrombin time ≤ 1.2 x ULN.
- International Normalized Ratio (INR) < 1.5.
- Bilirubin < 2 x ULN.
- Center of region of interest (ROI) (i.e., tumor site) ≥30mm deep to skull bone.
- If there is the potential for pregnancy, must agree to follow acceptable birth control methods to avoid conception.
- Able and willing to have their hair shaved (either whole head or the region where the coupling membrane will touch) and placement of peripheral IV line prior to treatment.
Who cannot join
- 1) Previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR), including bevacizumab.
- 2) New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening.
- 3) Hypertension (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).
- 4) Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- 5) Unstable Pulmonary Disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening.
- 6) Implanted pacemaker, defibrillator or deep brain stimulator, or other implanted electronic devices in the brain or documented clinically significant arrhythmias.
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- 7) Major surgery such as intra-thoracic, intra-abdominal or intra-pelvic (with the exception of craniotomy), open biopsy or significant traumatic injury ≤ 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to screening, or who have not recovered from side effects of such procedure or injury.
- 8) Known human immunodeficiency virus (HIV) positivity.
- 9) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of screening.
- 10) Pregnant or breast-feeding women.
- 11) Known sensitivity/allergy to MRI contrast agents, CT contrast agents, SonoVue® [Lumason®], bevacizumab, or any of their components.
- 12) Abnormal baseline findings considered by the Investigator to indicate conditions that might affect study endpoints.
- 13) Hemorrhage or cyst within the ROI.
- 14) ROI in the deep center brain with crucial brain functions, such as in the region of the brain stem.
- 15) The receipt of an investigational drug within a period of 4 weeks prior to the first FUS exposure.
- 16) Use of any recreational drugs or a history of drug addiction.
- 17) Difficulty lying supine and still for the FUS procedure length.
- 18) Any other condition that, in the Investigator's judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyle Wang, MD contact
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
Official title: An Open Label, Prospective, Pilot Study To Evaluate The Safety And Effectiveness Of The NaviFUS System In Conjunction With A Standard Treatment Regimen Of Bevacizumab (BEV) In Patients With Recurrent Glioblastoma
This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients.
Read the detailed description
The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported [Time Frame: Through study completion, up to 24 weeks].
To determine the incidence and severity of device-related AEs for bevacizumab plus NaviFUS System treatment in patients with recurrent glioblastoma multiforme (rGBM), the following safety parameters will be assessed: AEs, physical examination (PE), vital signs, neurological examination (NE), Karnofsky Performance Status (KPS), Mini-Mental State Examination (MMSE), clinical laboratory tests, proteinuria, and ECG.
- Conditions
- GBM
- Being tested
- NaviFUS System, Lumason, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviFUS SystemDevice
The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB. The NaviFUS System is indicated for use to enhance the permeability of conventionally administered therapeutic agents into targeted brain tissue to enhance their therapeutic effects.
LumasonDrug
The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB.
BevacizumabDrug
In this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients.
| Study group | Role | What they receive |
|---|---|---|
| NaviFUS + bevacizumab | Experimental | NaviFUS system with concomitant microbubble administration in conjunction with bevacizumab (BEV) Receives: Device: NaviFUS System; Drug: Lumason; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety -assessed using -Device-related Adverse Events (AEs) reported
The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported [Time Frame: Through study completion, up to 24 weeks].
Measured: Through study completion, up to 24 weeks
Secondary outcomes (9)
Progression-free survival at 6-months and 12-months as determined using the Radiologic Assessment in Neuro-Oncology (RANO) criteria.
The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
- Progression-free survival at 6-months and 12-months as determined using the Radiologic Assessment in Neuro-Oncology (RANO) criteria.
Measured: Pr6-months and 12-months
Median PFS at 6-months and 12-months as determined using the RANO criteria
The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
- Median PFS at 6-months and 12-months as determined using the RANO criteria
Measured: 6-months and 12-months
Objective response rate (ORR) as determined using the RANO criteria at Week 8, 16, and 24.
The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
- Objective response rate (ORR) as determined using the RANO criteria at Week 8, 16, and 24.
Measured: Week 8, 16, and 24.
Overall survival (OS) at 6 & 12 months.
The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
- Overall survival (OS) at 6 \& 12 months.
Measured: 6 & 12 months
Median OS at 18 months.
The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
- Median OS at 18 months.
Measured: 18 months.
Change in contrast enhancement (intensity) in MRI following BBB disruption at Week 8, 16, and 24 compared to baseline (Week 0).
The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
- Change in contrast enhancement (intensity) in MRI following BBB disruption at Week 8, 16, and 24 compared to baseline (Week 0).
Measured: Week 8, 16, and 24 compared to baseline (Week 0).
Change in corticosteroid use at Week 2, 4, 6, and 8 compared to baseline (Week 0).
The secondary objective of this clinical investigation is to evaluate the effectiveness of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
- Change in corticosteroid use at Week 2, 4, 6, and 8 compared to baseline (Week 0).
Measured: Week 2, 4, 6, and 8 compared to baseline (Week 0).
Change in quality of life (QoL) as determined by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) at Week 4, 8, and 16 compared to baseline (Week 0).
Change in quality of life (QoL) as determined by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) at Week 4, 8, and 16 compared to baseline (Week 0).
- Lower scores indicate better QoL out comes whereas higher scores indicate a poorer OoL outcomes.
- Minimum score is 0, Maximum score is: 112
Measured: Week 4, 8, and 16 compared to baseline (Week 0).
Change in quality of life (QoL) as determined by the Brain Cancer Questionnaire (BN20) at Week 4, 8, and 16 compared to baseline (Week 0).
Change in quality of life (QoL) as determined by the Brain Cancer Questionnaire (BN20) at Week 4, 8, and 16 compared to baseline (Week 0).
- Lower scores indicate better QoL out comes whereas higher scores indicate a poorer OoL outcomes.
- Minimum score is 0, Maximum score is: 112
Measured: Week 4, 8, and 16 compared to baseline (Week 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GBMStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- NaviFUS Corporation
- Responsible party
- Principal investigator, Kyle Wang, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274787
- Sponsor's protocol ID
- UCCC-BN-24-01
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Prospective, Pilot Study To Evaluate The Safety And Effectiveness Of The NaviFUS System In Conjunction With A Standard Treatment Regimen Of Bevacizumab (BEV) In Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07274787
- Acronym / sponsor ID
- UCCC-BN-24-01
- Conditions
- GBM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- NaviFUS Corporation
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and early effectiveness of the NaviFUS system with concomitant microbubble administration in conjunction with BEV in recurrent GBM patients.
Detailed description
The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM.
Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported [Time Frame: Through study completion, up to 24 weeks].
To determine the incidence and severity of device-related AEs for bevacizumab plus NaviFUS System treatment in patients with recurrent glioblastoma multiforme (rGBM), the following safety parameters will be assessed: AEs, physical examination (PE), vital signs, neurological examination (NE), Karnofsky Performance Status (KPS), Mini-Mental State Examination (MMSE), clinical laboratory tests, proteinuria, and ECG.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| NaviFUS + bevacizumab | Experimental | Device: NaviFUS System, Drug: Lumason, Drug: BevacizumabNaviFUS system with concomitant microbubble administration in conjunction with bevacizumab (BEV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Adult male/female patients ≥ 18 years of age.
- Histologically confirmed glioblastoma at original diagnosis, recurrent after prior radiotherapy and temozolomide chemotherapy.
- Must have measurable disease ≥ 10mm (according to RANO criteria) .
- Interval since completion of radiation treatment (including radiation at original diagnosis and/or radiation for recurrent disease) ≥ 12 weeks.
- If on steroids, must be on a stable dose for ≥ 7 days prior to study treatment.
Key exclusion criteria (18 listed)
- 1) Previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR), including bevacizumab.
- 2) New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening.
- 3) Hypertension (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg).
- 4) Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements.
- 5) Unstable Pulmonary Disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaviFUS SystemThe NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB. The NaviFUS System is indicated for use to enhance the permeability of conventionally administered therapeutic agents into targeted brain tissue to enhance their therapeutic effects. | Device | NaviFUS + bevacizumab |
| LumasonThe NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB. | Drug | NaviFUS + bevacizumab |
| BevacizumabIn this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients. | Drug | NaviFUS + bevacizumab |
Primary outcome
Safety -assessed using -Device-related Adverse Events (AEs) reported
Time frame: Through study completion, up to 24 weeks
The primary objective of this clinical investigation is to evaluate the safety of BEV combined with the NaviFUS System for the treatment of patients with recurrent GBM. Safety will be assessed using the following methods: Device-related Adverse Events (AEs) reported [Time Frame: Through study completion, up to 24 weeks].
9 secondary outcomes
Progression-free survival at 6-months and 12-months as determined using the Radiologic Assessment in Neuro-Oncology (RANO) criteria.
Time frame: Pr6-months and 12-months
Median PFS at 6-months and 12-months as determined using the RANO criteria
Time frame: 6-months and 12-months
Objective response rate (ORR) as determined using the RANO criteria at Week 8, 16, and 24.
Time frame: Week 8, 16, and 24.
Overall survival (OS) at 6 & 12 months.
Time frame: 6 & 12 months
Median OS at 18 months.
Time frame: 18 months.
Change in contrast enhancement (intensity) in MRI following BBB disruption at Week 8, 16, and 24 compared to baseline (Week 0).
Time frame: Week 8, 16, and 24 compared to baseline (Week 0).
Change in corticosteroid use at Week 2, 4, 6, and 8 compared to baseline (Week 0).
Time frame: Week 2, 4, 6, and 8 compared to baseline (Week 0).
Change in quality of life (QoL) as determined by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) at Week 4, 8, and 16 compared to baseline (Week 0).
Time frame: Week 4, 8, and 16 compared to baseline (Week 0).
Change in quality of life (QoL) as determined by the Brain Cancer Questionnaire (BN20) at Week 4, 8, and 16 compared to baseline (Week 0).
Time frame: Week 4, 8, and 16 compared to baseline (Week 0).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Wang, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviFUS System, Lumason and Bevacizumab in people with GBM, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety -assessed using -Device-related Adverse Events (AEs) reported (time frame: Through study completion, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.