Using spectral CT to check tumor response after TACE in hepatocellular carcinoma

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

This study tests whether spectral CT can better detect tumor response after TACE in adults with early-to-intermediate hepatocellular carcinoma.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhongda Hospital (other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT07351669 on ClinicalTrials.gov

What this trial studies

This prospective observational study compares the diagnostic performance of contrast-enhanced spectral CT versus conventional CT for detecting residual or recurrent tumor after TACE in patients with BCLC stage A or B hepatocellular carcinoma. Eligible adults (18–75) undergo spectral CT 4–8 weeks after TACE and may also have surgical resection, DSA hepatic arteriography, or contrast-enhanced MRI as reference standards; if those are not performed they enter scheduled imaging follow-up every three months for at least one year. The study measures how often spectral CT identifies viable tumor missed or confirmed by the reference standard and compares sensitivity, specificity, and diagnostic accuracy against conventional CT. The lead site is Zhongda Hospital, Southeast University, in Nanjing, China.

Who should consider this trial

Good fit: Adults aged 18–75 with pathologic or clinically diagnosed HCC (BCLC A or B) who have undergone TACE and are scheduled for follow-up imaging, angiography, or surgical resection.

Not a fit: Patients with advanced-stage HCC, non-HCC liver tumors, those outside the 18–75 age range, or those who cannot receive contrast-enhanced CT are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, spectral CT could more accurately identify residual viable tumor after TACE and help guide timely additional treatment or avoid unnecessary procedures.

How similar studies have performed: Prior single-center and smaller studies of dual-energy/spectral CT have suggested improved lesion characterization and detection of residual tumor after locoregional therapy, but large multicenter prospective confirmation is limited.

Eligibility 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.

Where this trial is running

Nanjing

• Zhongda Hospital Southeast University — Nanjing, China (RECRUITING)

Study contacts

• Study coordinator: Shuhang Zhang

Conditions: HCC - Hepatocellular Carcinoma, TACE, CT