Hepatocellular CarcinomaCEUS_LR_TRANCT07272083
New Diagnostic Criteria in the Evaluation Response to Ablation Treatment of Hepatocellular Carcinoma Nodules
An observational study of Hepatocellular Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Contrast-Enhanced Ultrasound
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2025to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrolled patients will be adults of both sexes with a diagnosis of HCC and an indication for locoregional thermal ablation with RFA or MWA, referred to the Diagnostic and Interventional Ultrasound Unit. As per clinical practice, after locoregional treatment and when the treated lesion is visible on B-mode imaging, patients will undergo CEUS approximately 24-48 hours after the procedure (early CEUS) and subsequently at about 4 weeks with CEUS (late CEUS) and MRI/CT
Who may be able to join
- Age greater than 18 years;
- HCC nodules treated with locoregional thermal ablation using RFA or MWA;
- Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario Gemelli IRCCS, Roma, Italia
Roma, 00168
Laura Riccardi, +39-0630155079, laura.riccardi@policlinicogemelli.it
About this study
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.
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.
Read more
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
- Hepatocellular Carcinoma
- Being tested
- Contrast-Enhanced Ultrasound
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced UltrasoundDiagnostic test
Application of the newly updated LI-RADS CEUS Non-Radiation TRA v2024 criteria in patients undergoing ultrasound-guided locoregional thermal ablation for HCC.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between CEUS LR-TRA and MRI/CT LR-TRA
Determining the concordance between CEUS LR-TRA and MRI/CT LR-TRA, by assessing the agreement between the two diagnostic techniques through the analysis of categorical variables.
Measured: 3 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Riccardi, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272083
- Sponsor's protocol ID
- 8154
- Acronym
- CEUS_LR_TRA
- Status last verified
- Sep 2026
- First submitted
- 26 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07272083
- Acronym / sponsor ID
- CEUS_LR_TRA / 8154
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled patients will be adults of both sexes with a diagnosis of HCC and an indication for locoregional thermal ablation with RFA or MWA, referred to the Diagnostic and Interventional Ultrasound Unit. As per clinical practice, after locoregional treatment and when the treated lesion is visible on B-mode imaging, patients will undergo CEUS approximately 24-48 hours after the procedure (early CEUS) and subsequently at about 4 weeks with CEUS (late CEUS) and MRI/CT
Key inclusion criteria (3 listed)
- Age greater than 18 years;
- HCC nodules treated with locoregional thermal ablation using RFA or MWA;
- Signed informed consent.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-Enhanced UltrasoundApplication of the newly updated LI-RADS CEUS Non-Radiation TRA v2024 criteria in patients undergoing ultrasound-guided locoregional thermal ablation for HCC. | Diagnostic test | – |
Primary outcome
Concordance between CEUS LR-TRA and MRI/CT LR-TRA
Time frame: 3 months after ablation
Determining the concordance between CEUS LR-TRA and MRI/CT LR-TRA, by assessing the agreement between the two diagnostic techniques through the analysis of categorical variables.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Riccardi principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Riccardi (+39-0630155079, laura.riccardi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between CEUS LR-TRA and MRI/CT LR-TRA (time frame: 3 months after ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.