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New Diagnostic Criteria in the Evaluation Response to Ablation Treatment of Hepatocellular Carcinoma Nodules

NCT07272083 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-12-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Contrast-Enhanced Ultrasound

Application of the newly updated LI-RADS CEUS Non-Radiation TRA v2024 criteria in patients undergoing ultrasound-guided locoregional thermal ablation for HCC.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Laura Riccardi · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-12-01
Completion
2029-12-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272083 on ClinicalTrials.gov