Using ultrasound to better diagnose liver lesions
Role of Contrast-enhanced Ultrasound (CEUS) and Shear Wave Elastography (SWE) to Characterize Focal Liver Lesions (FLLs)
This study is testing if advanced ultrasound techniques can help doctors better tell the difference between harmless and harmful liver lesions in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Trial ID | NCT05977764 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnostic accuracy of focal liver lesions (FLLs) using advanced ultrasound techniques. It will enroll 50 adult patients with detectable FLLs and utilize contrast-enhanced ultrasound (D-CEUS) and shear wave elastography (SWE) to gather quantitative data. The goal is to identify parameters that can help differentiate between benign and malignant liver lesions, potentially reducing the need for more invasive diagnostic procedures. The study will take place at the Policlinico Gemelli in Rome.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with focal liver lesions that can be detected by B-mode ultrasound.
Not a fit: Patients with liver or heart failure, previous treatments for liver lesions, or known allergies to ultrasound contrast agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive and more accurate diagnostic methods for patients with liver lesions.
How similar studies have performed: While the use of ultrasound in liver diagnostics is established, the specific combination of D-CEUS and SWE for this purpose is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * written informed consent * adult patients (more than 18 years old) * focal liver lesions detectable with B-mode ultrasound Exclusion Criteria: * liver failure, * hearth failure, * previous locoregional or systemic treatments for FLLs (e.g. ablation, chemoembolization, alcoholization, chemotherapy), * known allergy to ultrasound contrast agents * pregnancy * lactation
Where this trial is running
Roma
- Fondazione Policlinico Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Maria Assunta Zocco, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Maria Assunta Zocco
- Email: mariaassunta.zocco@policlinicogemelli.it
- Phone: 00393470597805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.