DETECT-HCC-ESLD is a prospective multicenter study designed to examine early detection and risk stratification of hepatocellular carcinoma (HCC) in individuals with advanced liver disease. Adults with cirrhosis of different etiologies are enrolled and followed longitudinally with structured clinical assessments and imaging at predefined intervals. A key objective is to evaluate ultrasound and abbreviated MRI (AMRI) as surveillance modalities for HCC. The study examines detection performance, feasibility, and factors influencing image quality and interpretability. The protocol also includes the study of body composition, focusing on how variations in adiposity and muscle mass may relate to imaging characteristics, disease progression, and HCC risk. Longitudinal clinical and imaging data are used to explore prediction models aimed at identifying patients with differing levels of HCC risk. The study records outcomes such as incident HCC, liver-related complications, and mortality to support analyses of disease trajectories. The DETECT-HCC-ESLD study provides a structured framework for collecting clinical, imaging, and body composition data over time, enabling detailed evaluation of surveillance strategies and risk patterns in advanced liver disease.
Study Type
OBSERVATIONAL
Enrollment
600
Department of gastroenterology and hepatology, University hospital in Linköping
Linköping, Select A State Or Province, Sweden
RECRUITINGLesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.
Time frame: Baseline visit
Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.
Time frame: Visit 2 (6 months)
Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.
Time frame: Visit 3 (12 months)
Lesion at high risk for hepatocellular carcinoma (HCC) - (LI RADS 4-5)
A nodule on MRI classified as LI-RADS 4 or 5 according to the American College of Radiology (ACR) LI-RADS criteria.
Time frame: Visit 4 (18 months)
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)
A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria
Time frame: Baseline visit
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)
A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria
Time frame: Visit 2 (6 months)
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)
A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria
Time frame: Visit 3 (12 months)
Lesion at high risk for hepatocellular carcinoma (HCC) - (US LI RADS 3)
A nodule on ultrasound classified as US LI-RADS 3 according to the American College of Radiology (ACR) LI-RADS criteria
Time frame: Visit 4 (18 months)
The Muscle Assessment Score (MAsS)
The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.
Time frame: Baseline visit
The Muscle Assessment Score (MAsS)
The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.
Time frame: Visit 2 (12 months)
The Muscle Assessment Score (MAsS)
The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.
Time frame: Visit 3 (12 months)
The Muscle Assessment Score (MAsS)
The Muscle Assessment Score (MAsS) combines thigh muscle z-score and muscle fat infiltration to detect muscle composition phenotypes.
Time frame: Visit 4 (18 months)
Liver associated clinical events (LACE)
Any of clinical ascites, variceal bleeding, hepatic encephalopathy west haven \>= grade 2, hepatorenal syndrome, or hepatopulmonary syndrome.
Time frame: From enrollment and six months after the last study visit (after a total of 24 months).
Hepatocellular carcinoma (HCC)
HCC verified by pathology.
Time frame: From enrollment and six months after last visit (a total of 24 months).
Treatment for hepatocellular carcinoma
Treatment given to patients that develope HCC: ablation, resection, TACE, systemic treatment, or best supportive care.
Time frame: From enrollment and six months after last visit (a total of 24 months).
Death
All cause mortality
Time frame: From enrollment and six months after last visit (a total of 24 months).
Liver stiffness (VCTE)
Liver stiffness measured with Fibroscan
Time frame: Baseline
Liver stiffness (VCTE)
Liver stiffness measured with Fibroscan
Time frame: Visit 2 (6 months)
Liver stiffness (VCTE)
Liver stiffness measured with Fibroscan
Time frame: Visit 3 (12 months)
Liver stiffness (VCTE)
Liver stiffness measured with Fibroscan
Time frame: Visit 4 (18 months)
Liver stiffness (MRE)
Liver stiffness measured with magnetic resonance elastography (MRE)
Time frame: Baseline
Liver stiffness (MRE)
Liver stiffness measured with magnetic resonance elastography (MRE)
Time frame: Visit 2 (6 months)
Liver stiffness (MRE)
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Liver stiffness measured with magnetic resonance elastography (MRE)
Time frame: Visit 3 (12 months)
Liver stiffness (MRE)
Liver stiffness measured with magnetic resonance elastography (MRE)
Time frame: Visit 4 (18 months)
Liver volume
Liver volume measured with MRI
Time frame: Baseline
Liver volume
Liver volume measured with MRI
Time frame: Visit 2 (6 months)
Liver volume
Liver volume measured with MRI
Time frame: Visit 3 (12 months)
Liver volume
Liver volume measured with MRI
Time frame: Visit 4 (18 months)
Spleen volume
Spleen volume measured with MRI
Time frame: Baseline
Spleen volume
Spleen volume measured with MRI
Time frame: Visit 2 (6 months)
Spleen volume
Spleen volume measured with MRI
Time frame: Visit 3 (12 months)
Spleen volume
Spleen volume measured with MRI
Time frame: Visit 4 (18 months)