New Diagnostic Criteria in the Evaluation Response to Ablation Treatment of Hepatocellular Carcinoma Nodules
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Hepatocellular carcinoma (HCC) is a primary liver malignancy that typically develops in the setting of chronic liver disease with a cirrhotic background. Currently, one of the main imaging techniques used to evaluate space-occupying lesions in the splanchnic district is contrast-enhanced ultrasound (CEUS), which is characterized by high sensitivity and specificity in lesion characterization through the assessment of enhancement patterns following contrast administration. When an HCC nodule is small (\<3 cm), hepatic function is preserved, and no extrahepatic disease is present, locoregional ultrasound-guided thermal ablation-either radiofrequency ablation (RFA) or microwave ablation (MWA)-is indicated as a treatment option. In 2024, the CEUS LI-RADS (Contrast-Enhanced Ultrasound Liver Imaging Reporting and Data System) criteria were further expanded to include the Non-Radiation Treatment Response Assessment (TRA). This represents a diagnostic algorithm applied to CEUS images to provide a standardized classification of treatment response following locoregional therapies or surgical resection of hepatic malignancies (HCC, intrahepatic cholangiocarcinoma, or mixed tumors) in patients at high risk for HCC. The algorithm focuses on evaluating the characteristics of any viable tumor remnants within or immediately adjacent to a treated lesion. The primary objective of this study is to assess the diagnostic accuracy of the newly updated LI-RADS CEUS Non-Radiation TRA v2024 criteria in patients undergoing ultrasound-guided locoregional thermal ablation for HCC. This prospective, observational, single-center study will enroll adult patients with a diagnosis of HCC who undergo RFA or MWA at our institution. Study results will be analyzed to determine the sensitivity, specificity, area under the curve (AUC), positive predictive value (PPV), and negative predictive value (NPV) of the CEUS LI-RADS Non-Radiation TRA criteria for the rule-in and rule-out of disease recurrence. The findings have the potential to improve patient prognosis and optimize clinical management strategies by reducing the use of second-level imaging modalities that involve ionizing radiation or nephrotoxic contrast agents.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek powyżej 18 lat
- •Rozpoznanie raka wątroby leczonego metodą ablacji cieplnej (radiofrekwencja lub mikrofale)
- •Podpisana świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Odmowa udziału w badaniu
- •Niemożliwość wykonania ultrasononografii po leczeniu z wstrzyknięciem kontrastu
- •Brak badania ultradźwiękowego w obserwacji po leczeniu
- •Niemożliwość wykonania tomografii lub rezonansu magnetycznego po leczeniu
- •Brak badań kontrolnych (tomografia lub rezonans) po leczeniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 9, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italia
Roma, Italy
Trial contact
Laura Riccardi
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/10/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.