MRMC: CT Image-assisted Detection Software for Focal Liver Lesions
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06068413
Collaborator
Ningbo No.2 Hospital (Other), Shenzhen Sixth People's Hospital (Other)
376
1
2
13
29
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
376 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
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
Actual Study Start Date
:
Apr 1, 2023
Anticipated Primary Completion Date
:
Apr 30, 2024
Anticipated Study Completion Date
:
Apr 30, 2024
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- AFROC [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Ningbo No.2 Hospital
- Shenzhen Sixth People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT06068413
Other Study ID Numbers:
- 2023-066
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University