Multimodal Ultrasound and Hepatocellular Response to Local Treatments

Study Overview
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Brief Summary
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Consecutive patients with HCC who should undergo to locoregional treatments (ablation or trans-arterial chemoembolization) according to international guidelines will be enrolled. atients will undergo CEUS and SWE before and after 24 hours from the procedure as per clinical practice in our center. Subsequently, the patients will continue the normal follow-up which includes control computed tomography/magnetic resonance one month after treatment and subsequently every three months.

Detailed Description
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Primary objective: To evaluate the correlation between pre-treatment ultrasound parameters (D-CEUS and elastography) and one-month response to therapy evaluated with contrast-enhanced computed tomography. Secondary objective: To identify quantitative ultrasound parameters able to predict overall survival and disease-free survival. Study design: Prospective single-center study. Methods: 50 consecutive patients with HCC who should undergo to locoregional treatments (ablation or trans-arterial chemoembolization) according to international guidelines will be enrolled in the Unit of Internal Medicine and Gastroenterology of the Policlinico Gemelli. After obtaining informed consent and identifying the target lesion in B-mode ultrasound, patients will undergo CEUS and SWE before and after 24 hours from the procedure as per clinical practice in our center. Subsequently, the patients will continue the normal follow-up which includes control computed tomography/magnetic resonance one month after treatment and subsequently every three months. In addition, the personal, clinical and laboratory data necessary to determine the hepatological scores of disease severity such as MELD and Child-Pugh will be collected. The study has an expected duration of one year.

Official Title
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Role of Dynamic Contrast-Enhanced Ultrasound (D-CEUS) and Shear-wave Elastography (SWE) in Predicting Response to Locoregional Treatments and Disease Recurrence in Patients Affected by Hepatocellular Carcinoma (HCC)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: multimodal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria adult patients with single nodule hepatocellular carcinoma detectable with B-mode ultrasound and scheduled for locoregional treatment Exclusion Criteria: liver failure previous treatments fo hepatocellular carcinoma chronic or acute heart failure known ipersesitivity to ultrasound contrast agent pregnancy and lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment | Diagnostic Test: multimodal ultrasound<br>* contrast-enhanced ultrasound and shear wave elastography on liver target lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predicting HCC response to treatment | to quantify peak enhancement intensity in Arbitray Units AU(measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC, stratified according to one-month treatment response (responders or non-responders) assessed by computed tomography | one month after local treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predicting HCC response to treatment | to quantify mean HCC stiffness in patients undergoing local treatments for HCC, stratified according to one-month treatment response (responders or non-responders) assessed by computed tomography | one month after local treatment | 
| predicting overall survival | to identify association between the peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC and time of survival | 12 months after treatment | 
| predicting disease-free survival | to identify the association between the peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients undergoing local treatments for HCC and time of disease-free survival | 12 months after treatment |