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

Southeast University

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT07351669

2025ZDSYLL494-P01

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.