Multimodal Ultrasound and Hepatocellular Response to Local Treatments
NCT ID: NCT05987514
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-10-07
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients
Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment
multimodal ultrasound
contrast-enhanced ultrasound and shear wave elastography on liver target lesion
Interventions
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multimodal ultrasound
contrast-enhanced ultrasound and shear wave elastography on liver target lesion
Eligibility Criteria
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Exclusion Criteria
* previous treatments fo hepatocellular carcinoma
* chronic or acute heart failure
* known ipersesitivity to ultrasound contrast agent
* pregnancy and lactation
18 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Zocco Maria Assunta
Prof
Locations
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Fondazione Policlinico Gemelli IRCCS
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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MARIA ASSUNTA ZOCCO, PhD
Role: primary
Other Identifiers
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4175
Identifier Type: -
Identifier Source: org_study_id
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