Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04667715
Status:
SUSPENDED
Last Update Posted:
2024-03-06
First Post:
2020-12-08
Brief Title:
Safety and Effectiveness of Blood-Brain Barrier Disruption BBBD in Subjects With Suspected Infiltrating Glioma
Sponsor:
InSightec
Organization:
InSightec
Study Overview
Official Title:
A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption BBBD in Subjects With Suspected Infiltrating Glioma
Status:
SUSPENDED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study suspended until priorities can be reassessed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BBBD
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of using the Exablate Type 2 system using microbubble resonators Exablate Test Arm to disrupt the Blood-Brain Barrier for the purpose of temporarily transforming and thereby marking regions of infiltrating gliomas prior to planned surgical resection for the purpose of improving tumor visualization during the surgery to achieve a greater proportion of subjects who receive a Gross Total Resection GTR per plan compared to those not undergoing a BBBD procedure prior to resection Control Arm
Detailed Description:
After being informed about the study and potential risks all patients giving written informed consent will undergo screening to determine eligibility for study entry Patients who meet the eligibility requirements will be randomized in a 21 ratio to Exablate Test Arm and to Control Arm respectively The following assessments will occur
1 Pre-surgical planning and Post-surgical visit MRI exams with and without contrast will be collected for evaluation by the study core lab Any return to surgery for additional resection will be captured
2 All subjects will be seen at Week 2 and 4-Weeks post resection for physical and neurological exams and to assess for complications or adverse events These visits should coincide with standard Neuro-oncology care following resection
3 Long-term outcomes will be collected during standard of care Neuro-oncology care follow-up visits for up to 2 years post resection standard of care MRIs and RANO assessments will be collected
1 Pre-surgical planning and Post-surgical visit MRI exams with and without contrast will be collected for evaluation by the study core lab Any return to surgery for additional resection will be captured
2 All subjects will be seen at Week 2 and 4-Weeks post resection for physical and neurological exams and to assess for complications or adverse events These visits should coincide with standard Neuro-oncology care following resection
3 Long-term outcomes will be collected during standard of care Neuro-oncology care follow-up visits for up to 2 years post resection standard of care MRIs and RANO assessments will be collected
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