Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178198
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-11-30
Brief Title:
Radiation Major Hepatectomy to Selectively Treat Large Unifocal Hepatocellular Carcinoma
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
An Open-label Single-arm Single-center Clinical Trial to Evaluate the Efficacy and Safety of Yttrium-90 Ablative Radioembolization Radiation Major Hepatectomy for Unifocal Large Hepatocellular Carcinoma
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:
RESCUE
Brief Summary:
The RESCUE trial is a prospective single-arm clinical study to evaluate the efficacy and safety of ablative radioembolization using Yttrium-90 This treatment is being investigated as a potential curative approach as well as a bridging or downstaging strategy for surgery in patients with large hepatocellular carcinoma greater than 8 cm who maintain good liver function
Detailed Description:
Patients presenting with large hepatocellular carcinoma greater than 8 cm whether accompanied by satellite nodules or not but retaining good liver function will undergo ablative radioembolization utilizing Yttrium-90 resin microspheres This approach is designed to deliver an ablative dose to both tumors and the surrounding liver ie margin with curative intent while preserving over 30 of the non-tumorous liver volume The efficacy and safety of this treatment will be evaluated over a period of two years and 90 days respectively
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NRF-2023R1A2C1006509 | OTHER_GRANT | National Research Fund of Korea | None |