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NCT Number: NCT07351669

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

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.

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Key information

Conditions

HCC - Hepatocellular Carcinoma Adenocarcinoma CT Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial TACE(Transcatheter Arterial Chemoembolization)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18-75 years;
  • diagnosis of HCC based on pathological findings or accepted clinical and imaging criteria;
  • Barcelona Clinic Liver Cancer (BCLC) stage A or B;
  • prior treatment with TACE;
  • undergoing contrast-enhanced spectral CT at 4-8 weeks after TACE;
  • undergoing either liver resection within 1 week after contrast-enhanced spectral CT (surgical cohort) or undergoing hepatic digital subtraction angiography (DSA) or contrast-enhanced MRI within 1 week after contrast-enhanced spectral CT (non-surgical cohort);
  • informed consent.

Exclusion criteria

  • contraindications to contrast-enhanced CT or MRI;
  • presence of extrahepatic malignancy;
  • poor image quality or incomplete clinical data;
  • lack of regular CT or MRI follow-up in non-surgical cohort;
  • withdrawal from the study.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shuhang Zhang

CONTACT

[email protected]

86 13852914095

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 20, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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