HCC - Hepatocellular CarcinomaNCT07351669
A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepatocellular Carcinoma
An observational study of HCC - Hepatocellular Carcinoma and TACE(Transcatheter Arterial Chemoembolization), run by Zhongda Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, TACE(Transcatheter Arterial Chemoembolization), CT
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Jun 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients recruited from six comprehensive medical centers nationwide
Who may be able to join
- age 18-75 years;
- diagnosis of HCC based on pathological findings or accepted clinical and imaging criteria;
- Barcelona Clinic Liver Cancer (BCLC) stage A or B;
- prior treatment with TACE;
- undergoing contrast-enhanced spectral CT at 4-8 weeks after TACE;
- 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);
- informed consent.
Who cannot join
- contraindications to contrast-enhanced CT or MRI;
- presence of extrahepatic malignancy;
- poor image quality or incomplete clinical data;
- lack of regular CT or MRI follow-up in non-surgical cohort;
- withdrawal from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Southeast University
Nanjing
Shuhang Zhang, 86 13852914095, shuhangzhang@outlook.com
About this study
Official title: The Performance of Spectral CT in Evaluating Treatment Response After Transarterial Chemoembolization for Hepatocellular Carcinoma: The SpecTRAIL Study
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.
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.
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.
Measured: From enrollment to the completion of the 1-year follow-up
Diagnostic Performance of Spectral CT for Residual Viable Hepatocellular Carcinoma After TACE.
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.
Measured: From enrollment to the completion of the 1-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Cheng Wang, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351669
- Sponsor's protocol ID
- 2025ZDSYLL494-P01
- Status last verified
- Jun 2026
- First submitted
- 29 Dec 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of Spectral CT in Evaluating Treatment Response After Transarterial Chemoembolization for Hepatocellular Carcinoma: The SpecTRAIL Study
- ClinicalTrials.gov ID
- NCT07351669
- Acronym / sponsor ID
- 2025ZDSYLL494-P01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients recruited from six comprehensive medical centers nationwide
Key inclusion criteria (7 listed)
- age 18-75 years;
- diagnosis of HCC based on pathological findings or accepted clinical and imaging criteria;
- Barcelona Clinic Liver Cancer (BCLC) stage A or B;
- prior treatment with TACE;
- undergoing contrast-enhanced spectral CT at 4-8 weeks after TACE;
Key exclusion criteria (5 listed)
- contraindications to contrast-enhanced CT or MRI;
- presence of extrahepatic malignancy;
- poor image quality or incomplete clinical data;
- lack of regular CT or MRI follow-up in non-surgical cohort;
- withdrawal from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions.
Time frame: From enrollment to the completion of the 1-year follow-up
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.
Diagnostic Performance of Spectral CT for Residual Viable Hepatocellular Carcinoma After TACE.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma and TACE(Transcatheter Arterial Chemoembolization), run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuhang Zhang (86 13852914095, shuhangzhang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of spectral CT in identifying nonviable HCC lesions. (time frame: From enrollment to the completion of the 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.