Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients

Trial Title: Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients

NCT ID: NCT05716620

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Conditions: Keywords:
HCC, cirrhosis, chronic liver disease, hepatitis B & C

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: MRI
Description: USG and MRI will be performed on the same day. US will be performed prior to MRI. There will be two rounds of screening 6 months apart using paired US and non-enhanced AMRI.

Other name: USG

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.

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.

Criteria for eligibility:

Study pop:
Patients will be evaluated by two rounds of screening 6 months apart using paired US and non- enhanced AMRI. First round of screening will be performed within 6 months of a negative imaging prior to recruitment in patients who fulfill the inclusion and exclusion criteria discussed above. US and AMRI will be performed on the same day. US will be performed prior to MRI. US & AMRI will be performed by the two radiologists independently. Fasting status will not be mandatory.Radiologists will be blinded to clinical details including the risk of HCC, tumor markers and to the results of other imaging tests.

Sampling method: Probability Sample
Criteria:
Inclusion Criteria: 1. Age>40 years 2. Presence of cirrhosis 3. Annual risk of HCC >5% 4. No HCC on pre-enrollment imaging not more than 6 months back. 5. Risk factors including diabetes mellitus, metabolic syndrome, family history of HCC. Exclusion Criteria: 1. Child C status 2. Diagnosed or follow up case of HCC 3. Other malignancies 4. Pregnancy, lactation 5. Contraindications to MRI (pacemaker, cochlear implant, claustrophobia) 6. Chronic renal disease or contrast allergy precluding administration of intravenous MRI contrast agent (for reference standard)

Gender: All

Minimum age: 40 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Post Graduate Institute of Medical Education and Research

Address:
City: Chandigarh
Zip: 160012
Country: India

Status: Recruiting

Contact:
Last name: Pankaj Gupta

Phone: 8194896927

Start date: February 8, 2022

Completion date: February 7, 2025

Lead sponsor:
Agency: Post Graduate Institute of Medical Education and Research, Chandigarh
Agency class: Other

Collaborator:
Agency: Indian Council of Medical Research
Agency class: Other

Source: Post Graduate Institute of Medical Education and Research, Chandigarh

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05716620