New Diagnostic Criteria to See How HCC Nodules Respond After Ablation
Official title: Application of the New Diagnostic Criteria CEUS (Contrast-Enhanced Ultrasound) LI-RADS (Liver Imaging Reporting and Data System) TRA (Nonradiation Treatment Response Assessment) in the Evaluation Response to Ablation Treatment (Radiofrequency or Microwave Ablation) of Hepatocellular Carcinoma (HCC) Nodules.
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07272083 · Data updated 2026-11-12
This study checks a new CEUS-based diagnostic approach to see if nodules after ablation respond as expected in people with hepatocellular carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 1, 2028 |
| Study ends | December 1, 2029 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07272083 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with hepatocellular carcinoma nodules previously treated with RFA or MWA and who can undergo post-treatment CEUS and CT/MRI follow-up.
✕Probably not a fit
Patients without post-treatment CEUS or follow-up imaging, or with contraindications to the imaging methods, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients with hepatocellular carcinoma who have undergone locoregional thermal ablation (RFA or MWA). It evaluates the use of contrast-enhanced ultrasound, guided by the updated CEUS LI-RADS TRA criteria, to assess treatment response after ablation. The goal is to determine how well this imaging approach reflects residual disease or successful ablation, guiding subsequent management. Eligible participants are adults with prior RFA or MWA treatment and who consent to post-treatment CEUS and follow-up CT or MRI imaging. Data will be collected from a single or few centers in Rome, Italy, under the coordination of the Fondazione Policlinico Universitario A. Gemelli IRCCS.
Why it matters
Potential benefit: If successful, the approach could improve accuracy in early detection of residual disease after ablation and inform timely decisions about further treatment.
How similar studies have gone: Previous work has shown CEUS-based assessment can accurately characterize liver lesions; this study explores a refined TRA-based approach in the post-ablation setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than 18 years; * HCC nodules treated with locoregional thermal ablation using RFA or MWA; * Signed informed consent. Exclusion Criteria: * Refusal to participate in the study; * Contraindications to performing post-treatment CEUS; * Absence of at least one CEUS examination during follow-up after locoregional thermal ablation with RFA or MWA; * Contraindications to performing post-treatment CT or MRI. * Absence of post-treatment CT or MRI follow-up imaging; * LR-TRA Nonevaluable categorization on post-treatment CT or MRI follow-up imaging.
Where it's running
-
Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italia
Roma, Italy Recruiting
Study contacts
- Principal investigator: Laura Riccardi — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Laura Riccardi
- Email: laura.riccardi@policlinicogemelli.it
- Phone: +39-0630155079
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.