Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496971
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-01
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
Sponsor:
NaviFUS Corporation
Organization:
NaviFUS Corporation
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 physicians 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
Detailed Description:
The study aims to compare the efficacy of combining Bevacizumab with NaviFUS System relative to Bevacizumab alone in patients with rGBM who have previously undergone radiotherapy and temozolomide chemotherapy
Any patient with a histological diagnosis of GBM who meets all of the specific eligibility criteria may participate in this study by signing informed consent in person or through their legal representative Eligible patients will undergo a 2-week baseline observation screening period
Up to 32 evaluable patients will be recruited in this study Eligible patients will be randomized in a 11 ratio with one group receiving the standard of care SoC BEV alone and the other group receiving treatment with microbubble-mediated FUS treatment in addition to BEV FUS-MBBEV
Eligible patients who assigned to the SoC group will follow the standard operating procedures of BEV 10 mgkg intravenous IV infusion over 30-90 minutes On the other hand eligible patients assigned to treatment group will initially receive the same BEV schedule After at least 30 minutes patients will be administered microbubbles MB SonoVue at a dose of 01 mLkg along with optimal ultrasound exposure doses determined by the acoustic emission feedback FUS power control algorithm of the NaviFUS System The treatment will be administered every 2 weeks up to 34 weeks or until evidence of progression disease PD intolerable toxicity precluding further treatment non- compliance with study follow-up or withdrawal of consent whichever occurs first
Any patient with a histological diagnosis of GBM who meets all of the specific eligibility criteria may participate in this study by signing informed consent in person or through their legal representative Eligible patients will undergo a 2-week baseline observation screening period
Up to 32 evaluable patients will be recruited in this study Eligible patients will be randomized in a 11 ratio with one group receiving the standard of care SoC BEV alone and the other group receiving treatment with microbubble-mediated FUS treatment in addition to BEV FUS-MBBEV
Eligible patients who assigned to the SoC group will follow the standard operating procedures of BEV 10 mgkg intravenous IV infusion over 30-90 minutes On the other hand eligible patients assigned to treatment group will initially receive the same BEV schedule After at least 30 minutes patients will be administered microbubbles MB SonoVue at a dose of 01 mLkg along with optimal ultrasound exposure doses determined by the acoustic emission feedback FUS power control algorithm of the NaviFUS System The treatment will be administered every 2 weeks up to 34 weeks or until evidence of progression disease PD intolerable toxicity precluding further treatment non- compliance with study follow-up or withdrawal of consent whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None