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Multimodal Ultrasound and Focal Liver Lesions (FLLs)

Primary Purpose

Liver Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondazione Policlinico Gemelli IRCCSRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lesion target

Arm Description

CEUS on lesion target

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2023
Last Updated
August 3, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05977764
Brief Title
Multimodal Ultrasound and Focal Liver Lesions (FLLs)
Official Title
Role of Contrast-enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) to Characterize Focal Liver Lesions (FLLs)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2020 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lesion target
Arm Type
Experimental
Arm Description
CEUS on lesion target
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
Contrast enhanced ultrasound
Primary Outcome Measure Information:
Title
to identify D-CEUS quantitative parameters useful for characterizing FLLs.
Description
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.
Time Frame
one month after liver biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Assunta Zocco
Phone
00393470597805
Email
mariaassunta.zocco@policlinicogemelli.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Assunta Zocco, PhD
Organizational Affiliation
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIA ASSUNTA ZOCCO, PhD
Phone
00393470597805

12. IPD Sharing Statement

Learn more about this trial

Multimodal Ultrasound and Focal Liver Lesions (FLLs)

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