Multimodal Ultrasound and Focal Liver Lesions (FLLs)

NCT05977764 | Unknown

• 1 other identifier: 2824
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

lesion target

EXPERIMENTAL

CEUS on lesion target

Other: Ultrasound

Interventions

Ultrasound OTHER

Contrast enhanced ultrasound

lesion target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent
• adult patients (more than 18 years old)
• focal liver lesions detectable with B-mode ultrasound

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Maria Assunta Zocco, PhD

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Assunta Zocco

CONTACT

00393470597805; mariaassunta.zocco@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: August 4, 2023
• Study Start: March 13, 2020
• Primary Completion: February 24, 2023
• Study Completion: December 30, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

IT (1)