[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NaviFUS Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,58,83,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100554275","phase-3-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-100554275",false,"NCT06496971","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","A Prospective, Randomized, Standard of Care Controlled, Parallel, Open-Label, Multicenter Pivotal Study to Evaluate the Efficacy and Safety of Avastin® in Combination With NaviFUS System Compared With Avastin® Alone for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of study enrollment.\n2. Body mass index (BMI) ≥ 17 kg\u002Fm2.\n3. Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.\n4. Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.\n5. Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual tumor ≤ 20 cm3.\n6. If patients are receiving corticosteroids, they must have been on a stable or decreasing dose of corticosteroids for at least 1 week prior to the planned first treatment.\n7. At the time of study enrollment, the minimum interval since the last event:\n\n   * 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\n   * 1 week out from minor surgical procedures or core biopsies\n8. Patients must have recovered from the toxic effects of prior therapy at the time of study enrollment as follows:\n\n   * 4 weeks out from any investigational drug or device\n   * 4 weeks out from chemotherapy\n   * 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., Carmustine (BCNU))\n   * 12 weeks out from completion of radiotherapy\n9. Patients should have a life expectancy ≥ 12 weeks.\n10. Patients must have Karnofsky Performance Status (KPS) ≥ 70.\n11. Adequate hematopoietic, renal, hepatic, and coagulation function, defined as:\n\n    * Hemoglobin ≥ 10 g\u002FdL\n    * Platelets ≥ 100,000\u002Fmm3\n    * Neutrophils ≥ 1,500\u002Fmm3\n    * Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n    * Urine protein creatinine ratio (UPCR) \\\u003C 1 or urine dipstick for proteinuria ≤ 2+\n    * Alanine aminotransferase (ALT) \\\u003C 3 × ULN\n    * Aspartate aminotransferase (AST) \\\u003C 3 × ULN\n    * Total bilirubin (TBL) \\\u003C 2 × ULN\n    * Prothrombin time ≤ 1.5 x ULN\n    * International Normalized Ratio (INR) \\\u003C 1.5 These tests must be conducted within 2 weeks prior to the planned first treatment.\n12. The central of FUS exposure region is located with a minimum distance of at least 30 mm beneath the skull bone.\n13. 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.\n14. 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 if assigned to treatment group.\n15. 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. Informed consent should also be given for biological materials and diagnostic imaging to be stored and used for future research on brain tumors.\n\nExclusion Criteria:\n\n1. Patients who have radiographic evidence of multifocal enhancing tumors.\n2. Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.\n3. Patients who have previously received Carmustine wafers implantation during re-operation.\n4. Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.\n5. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   * New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment\n   * Unstable angina pectoris\n   * Medical history of myocardial infarction within 6 months prior to study enrollment\n   * Cardiac shunt\n6. Stroke (except for transient ischemic attack; TIA) within 6 months prior to study enrollment.\n7. 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. Patients with contraindications for MRI as judged by Investigator, including non-MRI compatible metallic implant(s).\n8. Patients with inadequately controlled hypertension, defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg while on medication, within 2 weeks prior to first treatment.\n9. Patients with evidence of any thrombotic or hemorrhagic events, including but not limited to:\n\n   * Inherited bleeding diathesis or significant coagulopathy with the risk of bleeding (i.e., in the absence of therapeutic anticoagulation).\n   * History of pulmonary haemorrhage\u002Fhaemoptysis ≥ grade 2 according to the CTCAE version 5.0 criteria within 1 month prior to study enrollment\n   * Arterial or venous thrombosis (e.g., pulmonary embolism) within 3 months prior to study enrollment\n10. 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.\n11. Patients who have psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. Known HIV-positive patient, however, that HIV testing is not required for entry into this study.\n13. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study enrollment.\n14. History or evidence of active gastroduodenal ulcer, gastrointestinal perforations\u002Ffistula, or intra-abdominal abscess within 6 months prior to study enrollment.\n15. Receiving anticoagulant (e.g., warfarin or LMW heparin) or antiplatelet (e.g., aspirin) therapy within 1 week prior to beginning treatment.\n16. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, SonoVue®, Bevacizumab, or any of their components.\n17. Pregnant (positive pregnancy test) or breast-feeding women.\n18. Use of any recreational drugs or history of drug addiction.\n19. Other severe concurrent and\u002For 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.\n20. 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.","ALL","18 Years","80 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27,28,29,30,31,32,33,34],"Glioblastoma Multiforme","Glioblastoma","Glioblastoma Multiforme, Adult","Glioma","Brain Tumor","Brain Tumor, Recurrent","Neoplasms","Neoplasms, Nerve Tissue",[36,37,38,39,40,41,42,43,44],"NaviFUS System","Blood-Brain Barrier Opening","Focused Ultrasound","FUS","Low-Intensity Focused Ultrasound","LIFU","Bevacizumab","BEV","Avastin","RECRUITING","2026-04-06",{"date":48,"type":49},"2026-04-09","ACTUAL",{"date":51,"type":49},"2024-11-08",{"date":53,"type":21},"2027-03-31",{"name":55,"class":56},"NaviFUS Corporation","INDUSTRY",2,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":22,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":81,"locationsCount":82},"100553948","a-pilot-study-to-evaluate-the-efficacy-and-safety-of-navifus-system-neuromodulating-treatment-for-patients-with-drug-resistant-epilepsy-100553948","NCT06492720","A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","Inclusion Criteria:\n\n1. Male or female patients aged over than and equal to 18 years old.\n2. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.\n3. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.\n4. At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.\n5. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.\n\nExclusion Criteria:\n\n1. Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.\n2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).\n3. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.\n4. Image documented calcified lesion in the FUS exposure path.\n5. Abnormal coagulation profile:\n\n   1. Platelet (PLT) \\\u003C 100,000\u002FμL.\n   2. prothrombin time (PT) \\> 15 sec.\n   3. activated partial thromboplastin time (APTT) \\> 45 sec.\n   4. international normalized ratio (INR) \\> 1.5.\n   5. Patients requiring anticoagulant medications.\n6. Pregnant or breast-feeding women.\n7. Coexisting medical problems of sufficient severity to limit compliance with the study.\n8. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components; having metallic implants that are assessed as unsuitable for MRI examination.\n9. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.\n10. Patients have received an investigational drug or an investigational device within 4 weeks prior to the study\n11. Any other condition that, in the investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.\n12. Any ASM treatment change during the baseline (screening period).\n13. Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).\n14. Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).\n15. Patient has an IQ \\\u003C 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).\n16. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.","65 Years",{"count":67,"type":21},16,[69],"NA","This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).",[72,73,74,75],"Drug Resistant Epilepsy","Epilepsy","Epilepsy, Temporal Lobe","Seizures, Focal",[36,38,40,41],{"date":48,"type":49},{"date":79,"type":49},"2024-09-01",{"date":53,"type":21},{"name":55,"class":56},1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":100,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100545959","phase-1-a-safety-tolerability-and-preliminary-efficacy-of-low-intensity-focused-ultrasound-neuromodulation-in-patients-with-drug-resistant-epilepsy-100545959","NCT06388707","A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy","A Prospective, Open-label, Single-arm, Multi-center, Pilot Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Unilateral or Bilateral Temporal Lobe Epilepsy","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of enrollment.\n2. Patients with drug-resistant temporal lobe epilepsy (DR-TLE), defined as failure of adequate trials of two tolerated, appropriately chosen and used anti-epileptic drug schedules (whether as monotherapies or in combination).\n3. Focal-onset seizures with or without secondary generalization and no more than two known seizure onset zones (seizure foci), at least one which is in the mesial temporal lobe.\n4. At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.\n5. MRI and EEG within the past 3 years. At least one prior EEG should demonstrate interictal or ictal focal epileptiform findings.\n6. Patients with the central of FUS exposure region are located at least 30 mm distance beneath the skull bone.\n7. Patients must be on a stable regimen of anti-epileptic drugs (AEDs) for at least 30 days at the time of enrollment, except for rescue benzodiazepines or occasional extra doses of ongoing medicines, as required.\n8. Females of childbearing potential must have a negative pregnancy test prior to the first treatment. Females of childbearing potential and male patients with a partner of childbearing potential must agree to follow acceptable method of contraception (as outlined below) from prior to the first study treatment to 3 months after the last study treatment. Standard acceptable methods include use of highly effective method of contraception, including: hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, spermicide, vasectomy, intrauterine device, and abstinence from sex.\n9. Patients are able and willing to have their hair shaved in the region where the coupling membrane will touch (or if they prefer, whole head).\n10. Patients are able to complete all clinical trial-related questionnaires in English, including with the use of a suitable interpreter.\n11. Patients or their legal representatives are able to provide written informed consent for participation in the trial and comply with study requirements in the opinion of the Investigator during the study period.\n\nExclusion Criteria:\n\n1. Patients who have primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures.\n2. Patients who have experienced tonic-clonic status epilepticus in the 12 months before the time of enrollment in the study. Subjects with focal status epilepticus may be considered at the discretion of the Investigator.\n3. The only feasible sonication pathway to the seizure onset zones involves either:\n\n   1. Skull area is covered by previous surgical site(s), scars, scalp disorders (e.g., eczema, psoriasis), or scalp atrophy.\n   2. Clips or other metallic implanted objects in the skull or brain, except shunts.\n   3. A prior craniotomy site.\n4. Patients with a potentially acute or progressive neurologic disorder (e.g., brain tumor, multiple sclerosis, dementia, or intracranial vascular lesion).\n5. Implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator, deep brain stimulation (DBS), or other electronic devices implanted in the brain. If a patient has a working Vagus Nerve Stimulator (VNS) in place, the settings should remain stable throughout the trial and the device will be turned off prior to each sonication treatment and then turned back on afterward.\n6. Patients with severe depression, active suicidal ideation or behavior (as per the C-SSRS), active psychosis (excluding time-limited postictal psychosis), or psychiatric hospitalization in the year before time of enrollment.\n7. Patient has an IQ \\\u003C 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-II or other Wechsler IQ measure).\n8. Coexisting medical problems of sufficient severity to limit compliance with or interpretation of the study.\n9. Patients have received an investigational drug or an investigational device within 4 weeks prior to the first treatment.\n10. Radiofrequency thermocoagulation (RFTC) within 2 months before time of enrollment.\n11. Known history of substance or alcohol abuse within the past year, not counting marijuana.\n12. Pregnant or breast-feeding women.\n13. Any other condition that, in the Investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.",{"count":91,"type":21},8,[93,94],"PHASE1","PHASE2","This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).",[72,73,75,97,98],"Seizure","Seizure Disorder",[36,38,40,41],{"date":48,"type":49},{"date":102,"type":49},"2024-09-13",{"date":104,"type":21},"2027-05-31",{"name":55,"class":56},3,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":82},"100541415","phase-1-safety-and-efficacy-of-bevacizumab-in-combination-with-navifus-system-for-the-treatment-of-recurrent-glioblastoma-multiforme-rgbm-100541415","NCT06329570","Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)","A Prospective, Open-Label, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of study enrollment.\n2. Body mass index (BMI) ≥ 17 kg\u002Fm2.\n3. Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.\n4. Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.\n5. Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual tumor ≤ 20 cm3.\n6. If patients are receiving corticosteroids, they must have been on a stable or decreasing dose of corticosteroids for at least 1 week prior to the planned first treatment.\n7. At the time of study enrollment, the minimum interval since the last event:\n\n   * 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\n   * 1 week out from minor surgical procedures or core biopsies\n8. Patients must have recovered from the toxic effects of prior therapy at the time of study enrollment as follows:\n\n   * 4 weeks out from any investigational drug or device\n   * 4 weeks out from chemotherapy\n   * 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., Carmustine (BCNU))\n   * 12 weeks out from completion of radiotherapy\n9. Patients should have a life expectancy ≥ 12 weeks.\n10. Patients must have Karnofsky Performance Status (KPS) ≥ 70.\n11. Adequate hematopoietic, renal, hepatic, and coagulation function, defined as:\n\n    * Hemoglobin ≥ 10 g\u002FdL\n    * Platelets ≥ 100,000\u002Fmm3\n    * Neutrophils ≥ 1,500\u002Fmm3\n    * Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n    * Urine protein creatinine ratio (UPCR) \\\u003C 1 or urine dipstick for proteinuria ≤ 2+\n    * Alanine aminotransferase (ALT) \\\u003C 3 × ULN\n    * Aspartate aminotransferase (AST) \\\u003C 3 × ULN\n    * Total bilirubin (TBL) \\\u003C 2 × ULN\n    * Prothrombin time ≤ 1.5 x ULN\n    * International Normalized Ratio (INR) \\\u003C 1.5 These tests must be conducted within 2 weeks prior to the planned first treatment.\n12. 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.\n13. 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.\n14. 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.\n15. 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.\n\nExclusion Criteria:\n\n1. Patients who have radiographic evidence of multifocal enhancing tumors.\n2. Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.\n3. Patients who have previously received Carmustine wafers implantation during re-operation.\n4. Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.\n5. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   * New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment\n   * Unstable angina pectoris\n   * Medical history of myocardial infarction within 6 months prior to study enrollment\n   * Cardiac shunt\n6. Stroke (except for transient ischemic attack; TIA) within 6 months prior to study enrollment\n7. 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.\n8. Patients with inadequately controlled hypertension, defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg while on medication, within 2 weeks prior to first treatment.\n9. Patients with evidence of any thrombotic or hemorrhagic events, including but not limited to:\n\n   * Inherited bleeding diathesis or significant coagulopathy with the risk of bleeding (i.e., in the absence of therapeutic anticoagulation).\n   * History of pulmonary haemorrhage\u002Fhaemoptysis ≥ grade 2 according to the CTCAE version 5.0 criteria within 1 month prior to study enrollment.\n   * Arterial or venous thrombosis (e.g., pulmonary embolism) within 6 months prior to study enrollment.\n10. 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.\n11. Patients who have psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. Know HIV-positive patient, however, that HIV testing is not required for entry into this study.\n13. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study enrollment.\n14. History or evidence of active gastroduodenal ulcer, gastrointestinal perforations\u002Ffistula, or intra-abdominal abscess within 6 months prior to study enrollment.\n15. Receiving anticoagulant (e.g., warfarin or LMW heparin) or antiplatelet (e.g., aspirin) therapy within 1 week prior to beginning treatment.\n16. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, Lumason® , Avastin® , or any of their components.\n17. Pregnant (positive pregnancy test) or breast-feeding women.\n18. Use of any recreational drugs or history of drug addiction.\n19. Other concurrent severe and\u002For 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.\n20. 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.",{"count":115,"type":21},10,[93,94],"This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.",[27,28,30,31,33,34],[36,37,38,40,42,43],{"date":48,"type":49},{"date":122,"type":49},"2024-10-22",{"date":124,"type":21},"2028-03-31",{"name":55,"class":56},""]