Multimodal Ultrasound and Hepatocellular Response to Local Treatments
Role of Dynamic Contrast-Enhanced Ultrasound (D-CEUS) and Shear-wave Elastography (SWE) in Predicting Response to Locoregional Treatments and Disease Recurrence in Patients Affected by Hepatocellular Carcinoma (HCC)
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hepatocellular-carcinoma
Started Oct 2021
Typical duration for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2021
CompletedFirst Submitted
Initial submission to the registry
March 16, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedAugust 14, 2023
August 1, 2023
3 years
March 16, 2023
August 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
predicting HCC response to 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
one month after local treatment
Secondary Outcomes (3)
predicting HCC response to treatment
one month after local treatment
predicting overall survival
12 months after treatment
predicting disease-free survival
12 months after treatment
Study Arms (1)
Patients
EXPERIMENTALPatients affected by hepatocellular carcinoma needing to undergo loco-regional treatment
Interventions
contrast-enhanced ultrasound and shear wave elastography on liver target lesion
Eligibility Criteria
You may not qualify if:
- liver failure
- previous treatments fo hepatocellular carcinoma
- chronic or acute heart failure
- known ipersesitivity to ultrasound contrast agent
- pregnancy and lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Gemelli IRCCS
Roma, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
March 16, 2023
First Posted
August 14, 2023
Study Start
October 7, 2021
Primary Completion
October 1, 2024
Study Completion
June 1, 2025
Last Updated
August 14, 2023
Record last verified: 2023-08