Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329570
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-03-19
Brief Title:
Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme rGBM
Sponsor:
NaviFUS Corporation
Organization:
NaviFUS Corporation
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 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 physicians 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
Detailed Description:
The study aims to demonstrate the high safety profile and effectiveness of BEVFUS-MB targeted therapy for brain tumors
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 10 eligible patients will be enrolled in this study Eligible patients will follow the standard operating procedures of BEV 10 mgkg intravenous IV infusion over 30-90 minutes After at least 30 minutes patients will be administered microbubbles MB Lumason 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 10 eligible patients will be enrolled in this study Eligible patients will follow the standard operating procedures of BEV 10 mgkg intravenous IV infusion over 30-90 minutes After at least 30 minutes patients will be administered microbubbles MB Lumason 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?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None