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

NCT07351669 | Recruiting

• 1 other identifier: 2025ZDSYLL494-P01
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CT; HCC - Hepatocellular Carcinoma; TACE(Transcatheter Arterial Chemoembolization)

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.

  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.

  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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients recruited from six comprehensive medical centers nationwide

You may qualify if:

• Voluntary participation and ability to sign informed consent (post-TACE);
• Age between 18 and 75 years;
• Diagnosed as HCC based on pathology or clinical criteria, with a BCLC stage of A or B;
• Patients undergo contrast-enhanced spectral CT 4-8 weeks after treatment and are assessed as complete response on conventional CT images;
• 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.
• Voluntary participation and ability to sign informed consent (post-TACE, cTACE or DEB-TACE);
• Age between 18 and 75 years;
• Diagnosed as HCC based on pathology or clinical criteria, with a BCLC stage of A or B;
• Patients plan to undergo liver tumor resection following TACE downstaging therapy;
• Contrast-enhanced spectral CT was performed within 7 days before liver resection, after completion of TACE down-staging treatment.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Shuhang Zhang

CONTACT

86 13852914095; shuhangzhang@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiology

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)