Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Hepatocellular Carcinoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Drugs / interventionsRadiation
Locations1 site (Roma)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedDecember 1, 2028
Study endsDecember 1, 2029
Registry record updatedSeptember 9, 2026
Trial IDNCT07272083 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.