CT Image-assisted Detection Software for Focal Liver Lesions (MRMC)

February 5, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Retrospective, Multicenter, Multiple-viewer-multiple-case (MRMC) Clinical Trial to Evaluate the Safety and Efficacy of CT Image-assisted Detection Software for Focal Liver Lesions

To evaluate the safety and effectiveness of the developed and produced CT image-assisted detection software for focal liver lesions before being put into the market.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • doctors have liver CT scanning experience more than 1 year;

Exclusion Criteria:

  • persons don't have the license of practicing physician; doctors don't have liver CT scanning experience or have liver CT scanning experience less than 1 year;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-assisted diagnosis
Doctors diagnose the focal liver lesion with the help of AI.
Device: CT image-assisted detection software
CT image-assisted detection software can help doctor to diagnosis the focal liver lesion
No Intervention: common diagnosis
Doctors diagnose the focal liver lesion without the help of AI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AFROC
Time Frame: 1 year
Under different confidence scores, the number of accurately located lesions/the number of true lesions determined by the reference standard was taken as the ordinate coordinate, and (1- the number of negative cases determined by the reference standard/the total number of true negative cases diagnosed by the reference standard) was plotted as the horizontal coordinate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Ningbo No.2 Hospital
Shenzhen Sixth People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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