Multimodal Ultrasound and Hepatocellular Response to Local Treatments

Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987514
• Other study ID #: 4175
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: June 2025

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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• multimodal ultrasound
contrast-enhanced ultrasound and shear wave elastography on liver target lesion

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	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	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
Secondary	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
Secondary	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