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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07351669
Enrollment
121
Registered
2026-01-20
Start date
2026-01-20
Completion date
2028-06-30
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. age 18-75 years; 2. diagnosis of HCC based on pathological findings or accepted clinical and imaging criteria; 3. Barcelona Clinic Liver Cancer (BCLC) stage A or B; 4. prior treatment with TACE; 5. undergoing contrast-enhanced spectral CT at 4-8 weeks after TACE; 6. 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); 7. informed consent.

Exclusion criteria

1. contraindications to contrast-enhanced CT or MRI; 2. presence of extrahepatic malignancy; 3. poor image quality or incomplete clinical data; 4. lack of regular CT or MRI follow-up in non-surgical cohort; 5. withdrawal from the study.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.From enrollment to the completion of the 1-year follow-upTwo 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.
Diagnostic Performance of Spectral CT for Residual Viable Hepatocellular Carcinoma After TACE.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.

Countries

China

Contacts

CONTACTShuhang Zhang
shuhangzhang@outlook.com86 13852914095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026