Multimodal Ultrasound and Hepatocellular Response to Local Treatments
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Diagnostic Test: multimodal ultrasound
- Registration Number
- NCT05987514
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
- liver failure
- previous treatments fo hepatocellular carcinoma
- chronic or acute heart failure
- known ipersesitivity to ultrasound contrast agent
- pregnancy and lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients multimodal ultrasound Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Fondazione Policlinico Gemelli IRCCS
🇮🇹Roma, Italy