Hepatocellular Carcinoma
Conditions
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.
Interventions
DIAGNOSTIC_TESTmultimodal ultrasound
contrast-enhanced ultrasound and shear wave elastography on liver target lesion
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| predicting HCC response to treatment | one month after local 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
| Measure | Time frame | Description |
|---|---|---|
| predicting HCC response to treatment | one month after local 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 | 12 months after treatment | 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 | 12 months after treatment | 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 |
Countries
Italy
Contacts
Primary ContactMaria Assunta Zocco
Outcome results
None listed