Multimodal Ultrasound and Hepatocellular Response to Local Treatments
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
multimodal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma
Eligibility Criteria
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
Sites / Locations
- Fondazione Policlinico Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT05987514
First Posted
March 16, 2023
Last Updated
August 3, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05987514
Brief Title
Multimodal Ultrasound and Hepatocellular Response to Local Treatments
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
June 2025 (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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment
Intervention Type
Diagnostic Test
Intervention Name(s)
multimodal ultrasound
Intervention Description
contrast-enhanced ultrasound and shear wave elastography on liver target lesion
Primary Outcome Measure Information:
Title
predicting HCC response to treatment
Description
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
Time Frame
one month after local treatment
Secondary Outcome Measure Information:
Title
predicting HCC response to treatment
Description
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
Time Frame
one month after local treatment
Title
predicting overall survival
Description
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
Time Frame
12 months after treatment
Title
predicting disease-free survival
Description
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
Time Frame
12 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Assunta Zocco
Phone
00393470597805
Email
mariaassunta.zocco@policlinicogemelli.it
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 Hepatocellular Response to Local Treatments
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