Explorative Study for the Application of Dynamic Contrast-enhanced Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder (CEUS-PSVD)

NCT07492862 NA NOT_YET_RECRUITING

Porto-sinusoidal vascular disease (PSVD) is a rare clinical entity characterized by significant portal hypertension in the absence of cirrhosis on liver histology, which may or may not show specific alterations of the portal vein, sinusoids, or hepatic lobular architecture. Currently, diagnosis of this condition necessarily requires a liver biopsy and, despite some differences detected on imaging studies-and particularly on liver and spleen elastography-PSVD remains indistinguishable from cirrhosis using non-invasive tests. Contrast-enhanced ultrasound (CEUS) is an easy-to-perform, repeatable, and cost-effective examination that enables real-time assessment of parenchymal or focal liver lesion perfusion. Moreover, the application of dynamic contrast-enhanced ultrasound (DCE-US-i.e., contrast-enhanced ultrasound followed by quantitative perfusion analysis using dedicated software, such as the VueBox Software that will be used in this study) allows integration of CEUS qualitative assessment with quantitative evaluation of tissue perfusion through analysis of time-intensity curves generated during contrast transit. From this analysis, several perfusion-related parameters can be derived (for example, peak enhancement, time to peak, or area under the curve), which have already proven useful in improving differential diagnosis of focal liver lesions and in predicting treatment response and systemic therapy outcomes. To date, the use of DCE-US for the diagnosis of PSVD has not yet been described; however, based on the underlying histological alterations associated with this disease, it is reasonable to hypothesize that parameters obtained with this technique in the liver parenchyma of patients with PSVD may differ from those measured in patients with liver cirrhosis. The aim of the present project is to apply DCE-US in patients with PSVD and in patients with cirrhosis to evaluate potential significant differences in perfusion parameters, and to assess the feasibility of a non-invasive differential diagnosis between the two conditions using this technique in combination with elastography and bidimensional ultrasound data to develop a multiparametric diagnostic score.

Details

Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	100
Start date	2026-03
Completion	2028-12

Conditions

• Porto-sinusoidal Vascular Liver Disorder
• Liver Cirrhosis
• Portal Hypertension, Noncirrhotic
• Portal Hypertension Related to Cirrhosis
• Ultrasound Elastography
• Contrast-enhanced Ultrasound

Interventions

• Evaluation of quantitative perfusion parameters at dynamic contrast-enhanced ultrasound through Vuebox Software

Primary outcomes

• Peak enhancement (PE) measured on DCE-US (VueBox) — Baseline
  Maximum intensity of the signal in the time-intensity curve at dynamic contrast-enhanced ultrasound
• Time to peak (TTP) measured on DCE-US (VueBox) — Baseline
  The time required from the beginning of the exam to reach the peak enhancement
• Area under the time-intensity curve (AUC) measured on DCE-US (VueBox) — Baseline
  The total area under the time-intensity curve reflecting the quantity of contrast media passed through the region of interest
• Wash-in rate (slope) measured on DCE-US (VueBox) — Baseline
  Tangent at the ascending part of the time-intensity curve
• Mean Transit Time measured on DCE-US (VueBox) — Baseline
  Mean time taken by contrast to pass through the ROI
• Rise Time measured on DCE-US (VueBox) — Baseline
  Time from peak enhancement to point where tangent of ascending curve across x-axis

Countries

Italy