A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepatocellular Carcinoma

March 16, 2026 updated by: Yuan-Cheng Wang, Zhongda Hospital

The Performance of Spectral CT in Evaluating Treatment Response After Transarterial Chemoembolization for Hepatocellular Carcinoma: The SpecTRAIL Study

By comparing the diagnostic accuracy of spectral CT and conventional CT in evaluating treatment response efficacy after TACE, this study aims to investigate the diagnostic performance of spectral CT in assessing treatment response following TACE for hepatocellular carcinoma.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Nanjing, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients recruited from six comprehensive medical centers nationwide

Description

Inclusion Criteria01:

  1. Voluntary participation and ability to sign informed consent (post-TACE);
  2. Age between 18 and 75 years;
  3. Diagnosed as HCC based on pathology or clinical criteria, with a BCLC stage of A or B;
  4. Patients undergo contrast-enhanced spectral CT 4-8 weeks after treatment and are assessed as complete response on conventional CT images;
  5. Patients are scheduled to undergo surgical resection within one month, or DSA hepatic arteriography or contrast-enhanced MRI within one week. If none of these were planned, the patients were scheduled for imaging follow-up (CT or MRI) every 3 months (±15 days) for at least one year.

Inclusion Criteria02:

  1. Voluntary participation and ability to sign informed consent (post-TACE, cTACE or DEB-TACE);
  2. Age between 18 and 75 years;
  3. Diagnosed as HCC based on pathology or clinical criteria, with a BCLC stage of A or B;
  4. Patients plan to undergo liver tumor resection following TACE downstaging therapy;
  5. Contrast-enhanced spectral CT was performed within 7 days before liver resection, after completion of TACE down-staging treatment.

Exclusion Criteria:

  1. Contraindications to contrast-enhanced CT or contrast-enhanced MRI;
  2. Presence of extrahepatic malignancies;
  3. History of radiotherapy;
  4. Poor image quality or incomplete clinical/imaging data; Withdrawal from the study midway.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.
Time Frame: From enrollment to the completion of the 1-year follow-up
Two or more investigators independently evaluated the multiparametric spectral CT images of the patients using the mRECIST criteria. The imaging assessment results were recorded as CR, PR, PD, or SD. First, the agreement between spectral CT-based assessments and those obtained from conventional clinical CT was evaluated. Subsequently, the spectral CT imaging results were compared with the reference standard to assess the diagnostic accuracy of spectral CT.
From enrollment to the completion of the 1-year follow-up
Diagnostic Performance of Spectral CT for Residual Viable Hepatocellular Carcinoma After TACE.
Time Frame: From enrollment to the completion of the 1-year follow-up.

Imaging Assessment Criteria:

For target lesions, imaging evaluation was performed using the mRECIST and LI-RADS TRA v2024 criteria, with histopathological findings serving as the reference standard.

Imaging Assessment Procedure:

Two or more investigators independently and blindly reviewed the multiparametric spectral CT images of the patients. Lesions were assessed using the mRECIST criteria. The imaging assessment results were recorded as CR, PR, PD, or SD. The imaging findings were compared with the pathological reference standard to assess the diagnostic performance of spectral CT.
From enrollment to the completion of the 1-year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025ZDSYLL494-P01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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