Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04446416
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2020-06-16
Brief Title:
Efficacy and Safety of NaviFUS System add-on Bevacizumab BEV in Recurrent GBM Patients
Sponsor:
NaviFUS Corporation
Organization:
NaviFUS Corporation
Study Overview
Official Title:
An Open Label Prospective Pilot Study to Evaluate the Efficacy and Safety of Best Physicians Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2023-09
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 is a prospective single-arm two stages open-label pilot study to investigate the efficacy and safety of FUS add-on bevacizumab BEV in rGBM patients The BEV is the best physicians choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial Hospital Eligible patients will be enrolled through the process of informed consent
Detailed Description:
This trial will be divided into two stages The study design and procedures will be as follows
Stage 1
Eligible patients will first be administered with BEV 10 mgkg intravenous IV infusion After 30-60 minutes patients will receive microbubbles MB SonoVue 01 mLkg and optimal ultrasound exposure doses based on the acoustic emission feedback FUS power control algorithm generated from the NaviFUS System single exposure unit for up to two minutes every 2 weeks to transiently open the BBB
After 4 weeks of treatment with BEV and single unit FUS-MB treatment if the patient experienced BBB opening using FUS treatment and BEV IV infusion without any serious adverse effects such as brain significant bleeding then the patient may proceed to stage 2
Stage 2
Patients who complete stage 1 will enter stage 2 to receive the BEV with MB-mediated multiple units of FUS treatment for up to five minutes but the maximum exposure time per single unit is two minutes every 2 weeks for up to 30 weeks or until evidence of progressive disease unacceptable toxicity non-compliance with study follow-up or withdrawal of consent
After completion of study treatment patients will be followed up for 28 days
Stage 1
Eligible patients will first be administered with BEV 10 mgkg intravenous IV infusion After 30-60 minutes patients will receive microbubbles MB SonoVue 01 mLkg and optimal ultrasound exposure doses based on the acoustic emission feedback FUS power control algorithm generated from the NaviFUS System single exposure unit for up to two minutes every 2 weeks to transiently open the BBB
After 4 weeks of treatment with BEV and single unit FUS-MB treatment if the patient experienced BBB opening using FUS treatment and BEV IV infusion without any serious adverse effects such as brain significant bleeding then the patient may proceed to stage 2
Stage 2
Patients who complete stage 1 will enter stage 2 to receive the BEV with MB-mediated multiple units of FUS treatment for up to five minutes but the maximum exposure time per single unit is two minutes every 2 weeks for up to 30 weeks or until evidence of progressive disease unacceptable toxicity non-compliance with study follow-up or withdrawal of consent
After completion of study treatment patients will be followed up for 28 days
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