Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618300
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Streamlined Resin Y90 Radiation Segmentectomy for Small HCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Streamlined Resin Y90 Radiation Segmentectomy for Small HCC OneDone Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OneDone
Brief Summary:
This single-arm feasibility study evaluating the safety and efficacy of streamlining Yttrium-90 Y90 radioembolization workflow for patients with small Hepatocellular Carcinoma lt5cm that have no aggressive features on baseline imaging This study aims to recruit N30 patients prospectively and consolidate the current workflow of 2 days of procedures 1st-day mapping angiography followed by nuclear medicine hepatic lung shunt fraction LSF calculation using Tc99-MAA planar and SPECTCT and 2nd-day Y90 radioembolization followed by nuclear medicine Y90 SPECTCT into 1-day procedure Several studies have shown that hepatic LSF for HCC tumors smaller than 5cm in the absence of macrovascular invasion and portosystemic shunt placement is invariably lt10 Therefore the LSF calculation can be safely omitted from the complex workflow of these patients This study aims to illustrate that this can be done safely and efficaciously to reduce unnecessary patient travel and healthcare resource utilization Overall a total of 30 patients will be included in the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None