Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05716620
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2023-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients
Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Organization:
Study Overview
Official Title:
Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
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:
The goal of this study is Utility of abbrevational magnetic resonance imaging as a screening tool for hepatocellular carcinoma in cirrhotic patients.
The primary objective of the study is:
• HCC detection rate of US vs AMRI in cirrhotic patients
The secondary objective of the study are:
* False referral rate of US vs AMRI: false referral will be defined as lack of HCC on complete MRI despite a positive US or AMRI.
* Positive predictive value of US vs AMRI: The positive predictive value will be defined as the number of patients with true positive results in patients with positive US/AMRI.
Participants will be evaluated by two rounds of screening 6 months apart using paired US and non-enhanced AMRI.
The primary objective of the study is:
• HCC detection rate of US vs AMRI in cirrhotic patients
The secondary objective of the study are:
* False referral rate of US vs AMRI: false referral will be defined as lack of HCC on complete MRI despite a positive US or AMRI.
* Positive predictive value of US vs AMRI: The positive predictive value will be defined as the number of patients with true positive results in patients with positive US/AMRI.
Participants will be evaluated by two rounds of screening 6 months apart using paired US and non-enhanced AMRI.
Detailed Description:
Hepatocellular carcinoma (HCC) is the fifth most common cancer and is the second leading cause of cancer related death. The most important risk factor is cirrhosis of any etiology, particularly chronic hepatitis b and hepatitis c virus infection. Curative treatment (resection, transplant, or ablation) can be offered to patients diagnosed with early HCC. As the disease remains asymptomatic, most HCCs are diagnosed at an intermediate to terminal stage. Screening is an effective strategy to diagnose early HCC. The current guidelines recommend bi-annual screening with ultrasound (US) with or without alpha- fetoprotein (AFP). The overall sensitivity for detection of HCC using US screening is 60% while it is only 22% for detection of very early and early HCC. This results in many patients having progression of HCC despite being on screening program. Although computed tomography (CT) is widely available, the cumulative radiation dose from multiple screening CT scans makes CT screening unsuitable. Magnetic resonance imaging (MRI) has a high sensitivity and specificity for diagnosis of HCC owing to its high contrast resolution. A recent study showed significantly better sensitivity of HCC detection during screening using contrast enhanced MRI (CE-MRI) as compared with US. The use of CE-MRI entails high cost and risk of nephrogenic systemic fibrosis and is not well suited for screening from the health economics standpoint. Recently abbreviated MRI (AMRI) has been proposed as an acceptable alternative to US for HCC screening. AMRI involves acquisition of only a few MRI sequences rather than the complete MRI. This results in lesser table time and in turn reduced cost. However, most of the data is from retrospective studies. We propose a prospective study to evaluate the role of AMRI for HCC screening.
Study Oversight
Has Oversight DMC:
False
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?: