A Prototype Artificial Intelligence Algorithm Versus Liver Imaging Reporting and Data System (LI-RADS) Criteria in Diagnosing Hepatocellular Carcinoma on Computed Tomography: a Randomized Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to prospective validate this AI algorithm in comparison with the current standard of radiological reporting in a randomized manner in the at-risk population undergoing triphasic contrast CT. This research project is totally independent and separated from the actual clinical reporting of the CT scan by the duty radiologist. The primary study outcome is to compare the diagnostic performance of the prototype AI algorithm versus LI-RADS criteria in determining HCC on CT in the at-risk population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age \>=18 years.

• 2\. Defined as the at-risk population requiring regular liver ultrasonography surveillance.

∙ These include:

⁃ Cirrhotic patients of any disease etiology,

⁃ Chronic hepatitis B patients of age ≥40 years for men, age ≥50 years for women or with a family history of HCC.

‣ 3\. At least one new-onset focal liver nodule detected on liver ultrasonography.

Locations
Other Locations
Hong Kong Special Administrative Region
Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital
RECRUITING
Hong Kong
Department of Medicine, The University of Hong Kong, Queen Mary Hospital
NOT_YET_RECRUITING
Hong Kong
Contact Information
Primary
Wai-Kay Seto, MD
wkseto@hku.hk
85222553579
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 250
Treatments
Active_comparator: Prototype AI algorithm
In-house prototype deep learning artificial intelligence algorithm
Placebo_comparator: LI_RADS interpretation
LI-RADS criteria will be assessed independently by two specified abdominal radiologists with at least 10 years of experience in cross-sectional abdominal imaging
Related Therapeutic Areas
Sponsors
Collaborators: Education University of Hong Kong
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov

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