Multimodal Ultrasound and Focal Liver Lesions (FLLs)

Liver Neoplasms Clinical Trial

Official title:

Role of Contrast-enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) to Characterize Focal Liver Lesions (FLLs)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977764
• Other study ID #: 2824
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Maria Assunta Zocco
• Phone: 00393470597805
• Email: mariaassunta.zocco[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background and aim: FLLs are common findings in abdominal ultrasound and differential diagnosis between benign and malignant lesions is often challenging, especially in patients with chronic liver diseases. The diagnostic role of CEUS has already been defined by international guidelines when lesions show a typical pattern for hepatocellular carcinoma whereas in case of non-typical contrast enhanced patterns radiologic imaging or liver biopsy are still needed. However, these techniques are more invasive and expensive than ultrasound. Therefore, the aim of this study is to identify D-CEUS and SWE quantitative parameters useful for characterizing FLLs.

Study design: Prospective, observational, single-center study Methods: 50 consecutive adult patients with focal liver lesions detectable with B-mode ultrasound will be enrolled in the Unit of Internal Medicine and Gastroenterology of the Policlinico Gemelli. Exclusion criteria will be liver failure, hearth failure, previous locoregional or systemic treatments for FLLs (e.g. ablation, chemoembolization, alcoholization, chemotherapy), known allergy to ultrasound contrast agents. After obtaining informed consent and identifying the target lesion in B-mode ultrasound, patients will undergo CEUS and SWE and, subsequently, to computed tomography/magnetic resonance/biopsy according to international guidelines and current clinical practice. The average, maximum, minimum and standard deviation value of lesion elasticity in KPa will be calculated using SWE. Three consecutive SWE acquisitions will be performed both for the lesion and for the liver parenchyma and the average value of the three measurements will be considered. The CEUS will allow the construction of signal intensity curves as a function of time in a specific area of interest drawn manually. From these curves a series of quantitative parameters related to the flow and volume of blood will be extrapolated and in particular: peak intensity, PI (in Arbitrary Units, AU); time to peak, TP ( in seconds); area under the time curve, AUC (in AU); slope of the wash-in curve, Pw (in AU per second); average transit time, MTT (in seconds). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 30, 2024
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• written informed consent

• adult patients (more than 18 years old)

• focal liver lesions detectable with B-mode ultrasound

Exclusion Criteria:

• liver failure,

• hearth failure,

• previous locoregional or systemic treatments for FLLs (e.g. ablation, chemoembolization, alcoholization, chemotherapy),

• known allergy to ultrasound contrast agents

• pregnancy

• lactation

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Other:
• Ultrasound
Contrast enhanced ultrasound

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to identify D-CEUS quantitative parameters useful for characterizing FLLs.	to quantify peak enhancement intensity, PI (in Arbitrary Units, AU), measured by analysing D-CEUS time-intensity curves, in patients with FLLs undergoing liver biopsy and stratified according to the histologic exam.	one month after liver biopsy