Actively Recruiting

Age: 18Years - 75Years
All Genders
ID07351669

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

Led by Zhongda Hospital · Updated on 2026-03-19

250

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate how well spectral CT scans perform compared to conventional CT scans in assessing the treatment response after transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC). The focus is on determining the diagnostic accuracy of spectral CT in identifying nonviable tumor lesions and residual viable cancer following TACE. The study is led by Zhongda Hospital and includes patients aged 18 to 75 years with early to intermediate stage HCC. Participants undergo contrast-enhanced spectral CT scans 4 to 8 weeks after TACE treatment. Those assessed as having a complete response on conventional CT may then have surgical resection, hepatic arteriography, or contrast-enhanced MRI within a short time frame. If these procedures are not planned, patients receive imaging follow-up with CT or MRI every 3 months for at least one year. Another group includes patients who receive spectral CT within 7 days before liver tumor surgery following TACE downstaging therapy. During the study, researchers collect imaging data to evaluate the diagnostic performance of spectral CT. Participants are monitored through scheduled imaging and clinical assessments, with follow-up lasting at least one year from enrollment. The main outcomes measured are how accurately spectral CT identifies nonviable HCC lesions and detects residual viable tumors after TACE treatment. The study does not involve interventional treatments but focuses on observational imaging assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation and ability to sign informed consent after TACE
  • Age between 18 and 75 years
  • Diagnosed with hepatocellular carcinoma based on pathology or clinical criteria, with BCLC stage A or B
  • Underwent contrast-enhanced spectral CT 4 to 8 weeks after TACE and assessed as complete response on conventional CT
  • Scheduled for surgical resection within one month, or hepatic arteriography or contrast-enhanced MRI within one week, or imaging follow-up every 3 months for at least one year
  • Patients planning liver tumor resection after TACE downstaging therapy
  • Contrast-enhanced spectral CT performed within 7 days before liver resection after TACE downstaging treatment
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - From enrollment to completion of 1-year follow-up

Participants undergo contrast-enhanced spectral CT and other imaging assessments to evaluate treatment response after TACE.

Imaging follow-up every 3 months for at least one year

Trial Site Locations

Total: 1 location

1

Zhongda Hospital Southeast University

Nanjing, China

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Research Team

S

Shuhang Zhang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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