Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312826
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-09
Brief Title:
Abbreviated MRI Using Gadoxetic Acid Versus Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk
Sponsor:
So Yeon Kim
Organization:
Asan Medical Center
Study Overview
Official Title:
A Prospective Randomized Comparative Cohort Study to Investigate Abbreviated Magnetic Resonance Imaging Using Gadoxetic Acid and Ultrasonography for Surveillance of Early-stage HCC in Patients at High Risk for HCC
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Hepatocellular carcinoma HCC is the third most frequent cause of cancer-related deaths worldwide The incidence of HCC has been rapidly rising worldwide over the last two decades In order to improve survival with curative treatment regular surveillance to detect early-stage HCC is recommended for at-risk populations Although ultrasonography US has been endorsed as the primary surveillance tool for HCC a recent meta-analysis found that US has a sensitivity of 47 for detecting early-stage HCC and its sensitivity for detecting early-stage HCC has been questioned Many recent studies have explored the potential of alternative surveillance tools for HCC other than US particularly for high-risk patients Although complete gadoxetic acid-enhanced magnetic resonance imaging MRI demonstrated excellent performance its high cost and long examination time can hamper its widespread adoption Abbreviated MRI AMRI including hepatobiliary-phase imaging is a promising option to detect potential indicators of HCC maintaining the benefits of highly sensitive imaging while reducing the examination time by omitting dynamic contrast-enhanced imaging Because US is the current primary surveillance tool for HCC this new surveillance tool must be compared with US in a prospective randomized comparative design
Thus the hypothesis to be proved in this study is as follows AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC defined as an estimated annual HCC risk of higher than 5 We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate
Thus the hypothesis to be proved in this study is as follows AMRI with gadoxetic acid will show a significantly higher detection rate compared to US for the detection of early-stage HCC in patients with cirrhosis and at high risk of developing HCC defined as an estimated annual HCC risk of higher than 5 We will also analyze whether the false-referral rate of AMRI with gadoxetic acid is not compromised by its high detection rate
Detailed Description:
A total of 806 subjects will be randomized in a 11 ratio into the US group and the AMRI group Subjects will be evaluated by two rounds of tests with US or AMRI at intervals of 6 months After the completion of the two evaluation rounds at least 6 months of clinical follow-up data will be collected to record the occurrence of interval cancer
US group Subjects will be evaluated by two rounds of tests with abdominal US for the surveillance of HCC at intervals of 6 months
AMRI group Subjects will be evaluated by two rounds of tests with AMRI with gadoxetic acid for the surveillance of HCC at intervals of 6 months
US group Subjects will be evaluated by two rounds of tests with abdominal US for the surveillance of HCC at intervals of 6 months
AMRI group Subjects will be evaluated by two rounds of tests with AMRI with gadoxetic acid for the surveillance of HCC at intervals of 6 months
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 |
|---|---|---|---|
| 2022-0661 | OTHER | Asan Medical Center Institutional Review Board | None |