Clinical trial NCT05987514: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: predicting HCC response to treatment
timeFrame: one month after local treatment
Secondary outcomes:
measure: predicting HCC response to treatment
timeFrame: one month after local treatment
measure: predicting overall survival
timeFrame: 12 months after treatment
measure: predicting disease-free survival
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
References: