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Trial Title:
Multimodal Ultrasound and Hepatocellular Response to Local Treatments
NCT ID:
NCT05987514
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
multimodal ultrasound
Description:
contrast-enhanced ultrasound and shear wave elastography on liver target lesion
Arm group label:
Patients
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Gemelli IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
MARIA ASSUNTA ZOCCO, PhD
Phone:
00393470597805
Start date:
October 7, 2021
Completion date:
June 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05987514
