Clinical trial · Observational
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
NCT07351669CI-TRIAL-00114217recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CT | — | UNRESOLVED | — |
| HCC - Hepatocellular Carcinoma | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
| TACE(Transcatheter Arterial Chemoembolization) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.
- timeFrame
- From enrollment to the completion of the 1-year follow-up
- description
- 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.
- measure
- Diagnostic Performance of Spectral CT for Residual Viable Hepatocellular Carcinoma After TACE.
- timeFrame
- From enrollment to the completion of the 1-year follow-up.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.