?valuation of attenuation imaging (ATI) to elicit the degree of steatosis and shear wave dispersion mode (SWD) to quantify viscoelasticity in nonalcoholic steatohepatitis (NASH).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029983

Enrollment

244

Registered

2023-09-18

Start date

2023-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K76.0

Interventions

Group 1: Attenuation Imaging (ATI), Shear Wave Dispersion (SWD)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Signed informed consent from the patient or legal guardian; Substudy 1: patients with NASH/NAFLD; Substudy 2: patients with hepatologic disease (NASH/NAFLD, AIH, ASH, chronic hepatitis B infection, chronic hepatitis C infection) and existing histologic findings of the liver Age 18 years.

Exclusion criteria

Exclusion criteria: Incapacitated patients, pregnancy or lactation, patients with advanced liver cirrhosis and decompensation

Design outcomes

Primary

Measure	Time frame
Substudy 1: AUC, sensitivity and specificity of the degree of steatosis determined by Attenuation Imaging (ATI) by comparing the measured values with results of a CAP measurement and with results of a liver biopsy (histologically determined NAFLD activity score (NAS) and the Steatosis, Activity and Fibrosis Score (SAS), respectively). Substudy 2: AUC, sensitivity, and specificity of viscoelasticity determined by SWD by correlation with histologically assessed inflammation grade. Supplementary to Substudy 1 and 2: AUC, sensitivity and specificity of elasticity determined by SWE by comparing results with Transient Elastography (Fibroscan®) readings.	—

Measure

Time frame

Substudy 1: AUC, sensitivity and specificity of the degree of steatosis determined by Attenuation Imaging (ATI) by comparing the measured values with results of a CAP measurement and with results of a liver biopsy (histologically determined NAFLD activity score (NAS) and the Steatosis, Activity and Fibrosis Score (SAS), respectively). Substudy 2: AUC, sensitivity, and specificity of viscoelasticity determined by SWD by correlation with histologically assessed inflammation grade. Supplementary to Substudy 1 and 2: AUC, sensitivity and specificity of elasticity determined by SWE by comparing results with Transient Elastography (Fibroscan®) readings.

—

Secondary

Measure	Time frame
Influence of comorbidities on the diagnostic accuracy of the degree of steatosis and viscoelasticity (obesity (BMI), ascites).	—

Countries

Germany

Contacts

Public ContactMireen Friedrich-Rust

Medizinische Klinik 1, Goethe-Universität

mireen.friedrich-rust@kgu.de069 6301 5122

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026