Multimodal Ultrasound and Hepatocellular Response to Local Treatments

NCT ID: NCT05987514

Last Updated: 2023-08-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

Patients affected by hepatocellular carcinoma needing to undergo loco-regional treatment

Group Type EXPERIMENTAL

multimodal ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Exclusion Criteria

* liver failure
* previous treatments fo hepatocellular carcinoma
* chronic or acute heart failure
* known ipersesitivity to ultrasound contrast agent
* pregnancy and lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Zocco Maria Assunta

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maria Assunta Zocco

Role: CONTACT

00393470597805

Facility Contacts

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MARIA ASSUNTA ZOCCO, PhD

Role: primary

00393470597805

Other Identifiers

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4175

Identifier Type: -

Identifier Source: org_study_id

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