Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257030
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-02-05
Brief Title:
The AMARA As Much As Reasonably Achievable Study
Sponsor:
University Hospital of Patras
Organization:
University Hospital of Patras
Study Overview
Official Title:
The AMARA As Much As Reasonably Achievable Study Radioembolization of Large Inoperable Liver Tumors
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter For the purposes of the present study we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose 200Gy by the partition model The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors In addition to correlate the safety and efficacy with the post-treatment dosimetry analysis by MIM Software Inc based on 90Y-PETCT imaging
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None