Hepatocellular Carcinoma (HCC)NCT07768085
Pragmatic RCT of AI-Assisted Reading for Malignant Hepatic Lesions on CE-CT
A study testing AI-assisted abdominal CE-CT reporting and Standard abdominal CE-CT reporting without AI assistance in people with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (Icc), run by Shengjing Hospital at 1 site in China.
Trial summary
The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Hepatic Metastasis
- What is being tested?
- AI-assisted abdominal CE-CT reporting and Standard abdominal CE-CT reporting without AI assistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age range 18 years and above
- Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage
- Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional
- Complete imaging data that meet AI system and radiologist interpretation requirements.
Who cannot join
- History of recent upper-abdominal surgery (within 30 days) or major hepatobiliary-pancreatic surgery affecting liver evaluation (e.g., liver transplantation or Whipple procedure); patients with prior simple cholecystectomy or single-lesion interventional procedures are not excluded
- History of recent hepatic trauma (within 30 days)
- Poor image quality or severe noise artifacts (e.g., metal or motion artifacts)
- Missing required imaging phases (required at least non-contrast, arterial, and venous phases) or inadequate scan range (e.g., lower-abdomen CT such as pelvic or rectal scans not covering the liver)
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
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Yu MD PhD Shi, MD, +86 189 4025 9980, 18940259980@163.com
Yu Shi, MD, +86 189 4025 9980, 18940259980@163.com
About this study
Official title: A Multicenter Randomized Controlled Trial of AI-Assisted Reading Compared With Standard Radiology Interpretation for Malignant Hepatic Lesions on Contrast-Enhanced CT: Diagnostic, Clinical and Workflow Outcomes
The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, with the non-inferiority margin prespecified in the statistical analysis plan before enrollment, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.
Read the detailed description
Multiphasic contrast-enhanced computed tomography (CE-CT) is widely used to evaluate focal liver lesions, but clinically significant malignancies may be missed or incompletely characterized. This prospective, multicenter, pragmatic, cluster-randomized, center-day crossover trial will compare AI-assisted reporting with standard radiology reporting. Center-days will be assigned in an approximately 1:1 ratio using a centrally generated randomized sequence, and each participant will receive only one workflow. In the AI-assisted arm, the radiologist will save an unaided initial assessment before the locked AI output is revealed and may revise or retain the assessment before authorizing the final report. In the control arm, examinations will be interpreted without access to AI outputs. The primary outcome will be the proportion of participants with a reference-standard-confirmed clinically significant malignant focal liver lesion that was missed or inadequately characterized in the final report. The reference standard will incorporate histopathology, follow-up imaging, multidisciplinary consensus, and relevant clinical records. Non-inferiority will be assessed using a margin prespecified in the statistical analysis plan before enrollment, followed by superiority testing if non-inferiority is demonstrated. Secondary outcomes include senior-review workload, final report turnaround time, detection rate of clinically significant malignant liver lesions, clinically appropriate management-change rate, and time to initiation of treatment for liver malignancy.
- Conditions
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Hepatic Metastasis, Hepatic Hemangioma, Cyst, Focal Nodular Hyperplasia
- Being tested
- AI-assisted abdominal CE-CT reporting, Standard abdominal CE-CT reporting without AI assistance
- Keywords
- Dynamic Contrast-Enhanced CT, Focal Liver Lesions, Artificial intelligence, AI-assisted interpretation
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Cirrhosis, Familial, with Pulmonary Hypertension, Cysts, Focal Nodular Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted abdominal CE-CT reportingOther
After the unaided initial assessment is saved, the locked AI system will display lesion localization, patient-level and lesion-level malignancy probabilities, prespecified lesion-class suggestions, and uncertainty or technical-failure warnings. The first-line radiologist may revise or retain the initial assessment and must record acceptance, rejection, or uncertainty for clinically important AI suggestions. The senior reviewer may view the initial assessment, AI output, and revision history. AI may not autonomously authorize reports, prescribe management, or communicate diagnoses directly to participants.
Standard abdominal CE-CT reporting without AI assistanceOther
Eligible multiphasic abdominal CE-CT examinations will be interpreted and reported according to the site's standard radiology workflow, including routine senior review where applicable. AI system outputs will not be available to radiologists or clinical staff, and no AI-triggered safety-net review will be performed. Routine report addenda, urgent communication, multidisciplinary review, additional imaging, and subsequent clinical management will remain available according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| AI-on: AI-assisted abdominal CE-CT reporting | Experimental | Intervention: AI-assisted interpretation of abdominal CE-CT Receives: Other: AI-assisted abdominal CE-CT reporting |
| AI-off: Standard abdominal CE-CT reporting without AI assistance | Active comparator | Routine interpretation of abdominal CE-CT without access to AI system (standard of care) Receives: Other: Standard abdominal CE-CT reporting without AI assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-participant rate of missed clinically significant liver malignancy
Proportion of all enrolled participants with at least one reference-standard-confirmed clinically significant liver malignancy, including hepatocellular carcinoma, liver metastasis, or another primary hepatic malignancy, that was not identified or appropriately characterized in the final index CE-CT report. The reference standard will comprise histopathology when available; otherwise, 12-month imaging and clinical follow-up and relevant record linkage, adjudicated by an independent committee masked to allocation. Non-inferiority will be assessed against a margin prespecified before enrollment.
Measured: From the index CE-CT examination through 12 months
Secondary outcomes (5)
Senior-review workload
Number of examinations requiring senior radiologist review per 100 eligible CE-CT examinations, compared between AI-assisted and standard-reporting center-days.
Measured: Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
Final report turnaround time
Time in minutes from availability of the complete CE-CT examination for interpretation to authorization of the final clinical report.
Measured: Up to 24 hours after the complete CE-CT examination becomes available for interpretation
Detection rate of clinically significant malignant liver lesions
Proportion of enrolled participants with a reference-standard-confirmed clinically significant malignant liver lesion identified in the final index CE-CT report. Results will be reported overall and for prespecified subgroups, including confirmed HCC smaller than 2 cm, BCLC stage 0 HCC, and liver metastases stratified by primary tumor site.
Measured: From the index CE-CT examination through 12 months
Clinically appropriate management-change rate
Proportion of participants with an independently adjudicated change in diagnostic evaluation, referral, biopsy, treatment, or surveillance attributable to the final index CE-CT report, including avoidance of unnecessary downstream work-up.
Measured: From the index CE-CT examination through 12 months
Time to initiation of treatment for liver malignancy
Time in days from the index CE-CT examination to initiation of first anti-hepatic malignancy treatment (surgery, ablation, transarterial therapy, systemic therapy, or radiotherapy) among participants with reference-standard-confirmed malignant liver lesions. Median time and interquartile range will be reported, and the proportion of participants starting treatment within clinically relevant time thresholds (e.g., 30 days, 60 days, 90 days) will be compared between groups.
Measured: From the index CE-CT examination through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster-randomized, center-day crossover trial with participant-level parallel assignment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Shi, Shengjing Hospital
- Investigators
- Yu Shi, MD, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768085
- Sponsor's protocol ID
- SH-Lion2RCT--Intervention
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Elias-Cabot E, Romero-Martin S, Raya-Povedano JL, Rodriguez-Ruiz A, Alvarez-Benito M. AI-based triage and decision support in mammography and digital tomosynthesis for breast cancer screening: a paired, noninferiority trial. Nat Med. 2026 Apr;32(4):1296-1305. doi: 10.1038/s41591-026-04277-x. Epub 2026 Mar 19.
PubMed 41857202Woznitza N, Smith L, Rawlinson J, Au-Yong I, George B, Djearaman MG, Nair A, Lee RW, Navani N, Ndwandwe S, Clarke CS, Creeden A, Newsome J, Das I, Abaokporo S, Tucker R, Hathorn J, Baldwin DR. AI-based chest X-ray prioritization in the lung cancer diagnostic pathway: the LungIMPACT randomized controlled trial. Nat Med. 2026 May;32(5):1737-1744. doi: 10.1038/s41591-026-04253-5. Epub 2026 Mar 24.
PubMed 41876649Ding W, Meng Y, Ma J, Pang C, Wu J, Tian J, Yu J, Liang P, Wang K. Contrast-enhanced ultrasound-based AI model for multi-classification of focal liver lesions. J Hepatol. 2025 Aug;83(2):426-439. doi: 10.1016/j.jhep.2025.01.011. Epub 2025 Jan 21.
PubMed 39848548Ying H, Liu X, Zhang M, Ren Y, Zhen S, Wang X, Liu B, Hu P, Duan L, Cai M, Jiang M, Cheng X, Gong X, Jiang H, Jiang J, Zheng J, Zhu K, Zhou W, Lu B, Zhou H, Shen Y, Du J, Ying M, Hong Q, Mo J, Li J, Ye G, Zhang S, Hu H, Sun J, Liu H, Li Y, Xu X, Bai H, Wang S, Cheng X, Xu X, Jiao L, Yu R, Lau WY, Yu Y, Cai X. A multicenter clinical AI system study for detection and diagnosis of focal liver lesions. Nat Commun. 2024 Feb 7;15(1):1131. doi: 10.1038/s41467-024-45325-9.
PubMed 38326351
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of AI-Assisted Reading Compared With Standard Radiology Interpretation for Malignant Hepatic Lesions on Contrast-Enhanced CT: Diagnostic, Clinical and Workflow Outcomes
- ClinicalTrials.gov ID
- NCT07768085
- Acronym / sponsor ID
- SH-Lion2RCT--Intervention
- Conditions
- Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (Icc), Hepatic Metastasis, Hepatic Hemangioma, Cyst, Focal Nodular Hyperplasia
- Keywords
- Dynamic Contrast-Enhanced CT, Focal Liver Lesions, Artificial intelligence, AI-assisted interpretation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 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.
The purpose of this multicenter pragmatic randomized controlled trial is to determine whether AI-assisted interpretation of multiphasic liver contrast-enhanced computed tomography (CE-CT) is non-inferior to standard radiology reporting with respect to missed clinically significant malignant focal liver lesions, with the non-inferiority margin prespecified in the statistical analysis plan before enrollment, and whether it improves lesion detection, diagnostic characterization, downstream clinical management, and reporting efficiency. On AI-assisted center-days, AI results will be revealed only after the first-line radiologist has saved an unaided initial assessment and may be used to revise the final report. On control center-days, examinations will be interpreted using the standard radiology workflow without access to AI tools.
Detailed description
Multiphasic contrast-enhanced computed tomography (CE-CT) is widely used to evaluate focal liver lesions, but clinically significant malignancies may be missed or incompletely characterized. This prospective, multicenter, pragmatic, cluster-randomized, center-day crossover trial will compare AI-assisted reporting with standard radiology reporting. Center-days will be assigned in an approximately 1:1 ratio using a centrally generated randomized sequence, and each participant will receive only one workflow. In the AI-assisted arm, the radiologist will save an unaided initial assessment before the locked AI output is revealed and may revise or retain the assessment before authorizing the final report. In the control arm, examinations will be interpreted without access to AI outputs. The primary outcome will be the proportion of participants with a reference-standard-confirmed clinically significant malignant focal liver lesion that was missed or inadequately characterized in the final report. The reference standard will incorporate histopathology, follow-up imaging, multidisciplinary consensus, and relevant clinical records. Non-inferiority will be assessed using a margin prespecified in the statistical analysis plan before enrollment, followed by superiority testing if non-inferiority is demonstrated. Secondary outcomes include senior-review workload, final report turnaround time, detection rate of clinically significant malignant liver lesions, clinically appropriate management-change rate, and time to initiation of treatment for liver malignancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A cluster-randomized, center-day crossover trial with participant-level parallel assignment.
| Arm | Type | Receives |
|---|---|---|
| AI-on: AI-assisted abdominal CE-CT reporting | Experimental | Other: AI-assisted abdominal CE-CT reportingIntervention: AI-assisted interpretation of abdominal CE-CT |
| AI-off: Standard abdominal CE-CT reporting without AI assistance | Active comparator | Other: Standard abdominal CE-CT reporting without AI assistanceRoutine interpretation of abdominal CE-CT without access to AI system (standard of care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range 18 years and above
- Underwent dynamic contrast-enhanced abdominal CT examination with liver coverage
- Imaging must include at least three required phases: non-contrast, arterial phase, and venous phase; a delayed phase is optional
- Complete imaging data that meet AI system and radiologist interpretation requirements.
Key exclusion criteria (4 listed)
- History of recent upper-abdominal surgery (within 30 days) or major hepatobiliary-pancreatic surgery affecting liver evaluation (e.g., liver transplantation or Whipple procedure); patients with prior simple cholecystectomy or single-lesion interventional procedures are not excluded
- History of recent hepatic trauma (within 30 days)
- Poor image quality or severe noise artifacts (e.g., metal or motion artifacts)
- Missing required imaging phases (required at least non-contrast, arterial, and venous phases) or inadequate scan range (e.g., lower-abdomen CT such as pelvic or rectal scans not covering the liver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted abdominal CE-CT reportingAfter the unaided initial assessment is saved, the locked AI system will display lesion localization, patient-level and lesion-level malignancy probabilities, prespecified lesion-class suggestions, and uncertainty or technical-failure warnings. The first-line radiologist may revise or retain the initial assessment and must record acceptance, rejection, or uncertainty for clinically important AI suggestions. The senior reviewer may view the initial assessment, AI output, and revision history. AI may not autonomously authorize reports, prescribe management, or communicate diagnoses directly to participants. | Other | AI-on: AI-assisted abdominal CE-CT reporting |
| Standard abdominal CE-CT reporting without AI assistanceEligible multiphasic abdominal CE-CT examinations will be interpreted and reported according to the site's standard radiology workflow, including routine senior review where applicable. AI system outputs will not be available to radiologists or clinical staff, and no AI-triggered safety-net review will be performed. Routine report addenda, urgent communication, multidisciplinary review, additional imaging, and subsequent clinical management will remain available according to standard clinical practice. | Other | AI-off: Standard abdominal CE-CT reporting without AI assistance |
Primary outcome
Per-participant rate of missed clinically significant liver malignancy
Time frame: From the index CE-CT examination through 12 months
Proportion of all enrolled participants with at least one reference-standard-confirmed clinically significant liver malignancy, including hepatocellular carcinoma, liver metastasis, or another primary hepatic malignancy, that was not identified or appropriately characterized in the final index CE-CT report. The reference standard will comprise histopathology when available; otherwise, 12-month imaging and clinical follow-up and relevant record linkage, adjudicated by an independent committee masked to allocation. Non-inferiority will be assessed against a margin prespecified before enrollment.
5 secondary outcomes
Senior-review workload
Time frame: Up to 24 hours after the eligible CE-CT examination becomes available for interpretation
Final report turnaround time
Time frame: Up to 24 hours after the complete CE-CT examination becomes available for interpretation
Detection rate of clinically significant malignant liver lesions
Time frame: From the index CE-CT examination through 12 months
Clinically appropriate management-change rate
Time frame: From the index CE-CT examination through 12 months
Time to initiation of treatment for liver malignancy
Time frame: From the index CE-CT examination through 12 months
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 17 Aug 2026.
- Background: PubMed 41857202Elias-Cabot E, Romero-Martin S, Raya-Povedano JL, Rodriguez-Ruiz A, Alvarez-Benito M. AI-based triage and decision support in mammography and digital tomosynthesis for breast cancer screening: a paired, noninferiority trial. Nat Med. 2026 Apr;32(4):1296-1305. doi: 10.1038/s41591-026-04277-x. Epub 2026 Mar 19.
- Background: PubMed 41876649Woznitza N, Smith L, Rawlinson J, Au-Yong I, George B, Djearaman MG, Nair A, Lee RW, Navani N, Ndwandwe S, Clarke CS, Creeden A, Newsome J, Das I, Abaokporo S, Tucker R, Hathorn J, Baldwin DR. AI-based chest X-ray prioritization in the lung cancer diagnostic pathway: the LungIMPACT randomized controlled trial. Nat Med. 2026 May;32(5):1737-1744. doi: 10.1038/s41591-026-04253-5. Epub 2026 Mar 24.
- Background: PubMed 39848548Ding W, Meng Y, Ma J, Pang C, Wu J, Tian J, Yu J, Liang P, Wang K. Contrast-enhanced ultrasound-based AI model for multi-classification of focal liver lesions. J Hepatol. 2025 Aug;83(2):426-439. doi: 10.1016/j.jhep.2025.01.011. Epub 2025 Jan 21.
- Background: PubMed 38326351Ying H, Liu X, Zhang M, Ren Y, Zhen S, Wang X, Liu B, Hu P, Duan L, Cai M, Jiang M, Cheng X, Gong X, Jiang H, Jiang J, Zheng J, Zhu K, Zhou W, Lu B, Zhou H, Shen Y, Du J, Ying M, Hong Q, Mo J, Li J, Ye G, Zhang S, Hu H, Sun J, Liu H, Li Y, Xu X, Bai H, Wang S, Cheng X, Xu X, Jiao L, Yu R, Lau WY, Yu Y, Cai X. A multicenter clinical AI system study for detection and diagnosis of focal liver lesions. Nat Commun. 2024 Feb 7;15(1):1131. doi: 10.1038/s41467-024-45325-9.
- Individual participant dataSharing planned: Yes
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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.
Yu Shi, MD principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted abdominal CE-CT reporting and Standard abdominal CE-CT reporting without AI assistance in people with Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (Icc), run by Shengjing 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 17 Aug 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 Yu MD PhD Shi (+86 189 4025 9980, 18940259980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-participant rate of missed clinically significant liver malignancy (time frame: From the index CE-CT examination through 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07768085, which also lists 4 linked publications.
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 17 Aug 2026.