Artificial intelligence assisting physicians in detection of focal liver lesions from real-time ultrasonography

Phase 2

Completed

• Conditions: hepatocellular carcinoma; ultrasonography; hepatocellular carcinomaliver cysthemangiomafocal fatty sparingfocal fatty infiltration; artificial intelligence; convolutional neural network; computer aided; focal liver lesion; screening and surveillance; deep learning

• Registration Number: TCTR20201230003
• Lead Sponsor: Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-30
• Study Completion: 2022-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

Patients who meet diagnostic criteria of the following focal liver lesions:
1. Hepatocellular carcinoma (HCC). Pathology results will be considered first. If there is no pathology result, CT and/or MRI results within 3 months before or after the index ultrasound date will be considered.
2. Liver cysts. Simple cysts can be diagnosed solely by ultrasound. However, diagnosis of complicated cysts requires confirmatory CT and/or MRI. Additionally, size of the lesion must also be stable during at least 2-year interval.
3. Hemangioma. CT/MRI results will be used as gold standard for diagnosis. If there is no CT/MRI, typical hemangioma (round homogeneous bright hyperechoic lesion on ultrasound) can be diagnosed by follow-up criteria, i.e., at least 2 ultrasound studies demonstrating size stability during at least 2-year interval.
4. Focal fatty sparing. CT/MRI will be considered first. If there is no CT/MRI, ultrasound diagnosis will be accepted only if the lesion has typical shape (geographic-shaped homogeneous hypoechoic lesion), and is located in typical area of the liver (peri-portal or peri-gallbladder). Size of the lesion must also be stable during at least 2-year interval.
5. Focal fatty infiltration. CT/MRI will be considered first. If there is no CT/MRI, ultrasound diagnosis will be accepted only if the lesion has typical shape (geographic-shaped homogeneous hyperechoic lesion), and is located in typical area of the liver (peri-portal or peri-gallbladder). Size of the lesion must also be stable during at least 2-year interval.

Patients without focal liver lesions, by one of the following criteria:
1. has CT/MRI within 6 months before or after ultrasound performing in the study arms, confirming that there is no focal liver lesion.
2. At least 2 ultrasound studies demonstrating no focal liver lesion, with at least one ultrasound study performed within 6 months before or after ultrasound performing in the study arms.

Exclusion Criteria

1. Patients with polycystic liver disease
2. HCCs previously treated by locoregional methods

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection rate of focal liver lesions after enrollment is completed detection rate

Secondary Outcome Measures

Name	Time	Method
false positive detections of focal liver lesions after enrollment is completed false positive detections,detection rates stratified by diagnoses of focal liver lesions after enrollment is completed detection rate