Ignite Creation Date:
2024-05-06 @ 4:25 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04988750
Status:
RECRUITING
Last Update Posted:
2023-09-06
First Post:
2021-07-02
Brief Title:
Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients
Sponsor:
NaviFUS Corporation
Organization:
NaviFUS Corporation
Study Overview
Official Title:
An Open Label Prospective Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Combination of Focused Ultrasound With Re-irradiation for the Treatment Patients With Recurrent Glioblastoma Multiforme Using NaviFUS System
Status:
RECRUITING
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 an open label single arm prospective and pilot study Eligible patients will be enrolled after acquiring the signed informed consent and then will receive the treatment of re-RT combined with FUS FUS re-RT on an outpatient basis The re-RT in FUS re-RT treatment will include fractioned stereotactic radiosurgery SRS treatment FUS SRS or conventional radiotherapy cRT treatment FUS cRT The treatment of SRS or cRT treatment given to patients is determined by the investigator depending on the volume and location of the treatment region
Detailed Description:
None
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