Focal Liver LesionMRMCNCT06068413
CT Image-assisted Detection Software for Focal Liver Lesions
A study testing CT image-assisted detection software in people with Focal Liver Lesion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Liver Lesion
- What is being tested?
- CT image-assisted detection software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- doctors have liver CT scanning experience more than 1 year;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
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
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.
- Conditions
- Focal Liver Lesion
- Being tested
- CT image-assisted detection software
- Keywords
- CT image-assisted detection software, focal liver lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT image-assisted detection softwareDevice
CT image-assisted detection software can help doctor to diagnosis the focal liver lesion
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted diagnosis | Experimental | Doctors diagnose the focal liver lesion with the help of AI. Receives: Device: CT image-assisted detection software |
| common diagnosis | No intervention | Doctors diagnose the focal liver lesion without the help of AI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
AFROC
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Apr 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal Liver LesionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Shenzhen Sixth People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068413
- Sponsor's protocol ID
- 2023-066
- Acronym
- MRMC
- Status last verified
- Apr 2023
- First submitted
- 28 Sep 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sun Z, Chen Y, Ding H, Chen Y, Cao H, Han X, Chen W, Wu L, Fang F, Wu F, Yang L, Bu J, Ding Y, Wang W. Assessing the Impact of MULLET AI System on Focal Liver Lesion Detection: A Multicenter, Multi-reader, Multi-case Clinical Trial. NPJ Precis Oncol. 2026 Jul 9. doi: 10.1038/s41698-026-01594-9. Online ahead of print.
PubMed 42426202
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06068413
- Acronym / sponsor ID
- MRMC / 2023-066
- Conditions
- Focal Liver Lesion
- Keywords
- CT image-assisted detection software, focal liver lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Shenzhen Sixth People's Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 5 Oct 2023 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted diagnosis | Experimental | Device: CT image-assisted detection softwareDoctors diagnose the focal liver lesion with the help of AI. |
| common diagnosis | No intervention | –Doctors diagnose the focal liver lesion without the help of AI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- doctors have liver CT scanning experience more than 1 year;
Key exclusion criteria (1 listed)
- 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;
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 |
|---|---|---|
| CT image-assisted detection softwareCT image-assisted detection software can help doctor to diagnosis the focal liver lesion | Device | AI-assisted diagnosis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Derived from this study: PubMed 42426202Sun Z, Chen Y, Ding H, Chen Y, Cao H, Han X, Chen W, Wu L, Fang F, Wu F, Yang L, Bu J, Ding Y, Wang W. Assessing the Impact of MULLET AI System on Focal Liver Lesion Detection: A Multicenter, Multi-reader, Multi-case Clinical Trial. NPJ Precis Oncol. 2026 Jul 9. doi: 10.1038/s41698-026-01594-9. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT image-assisted detection software in people with Focal Liver Lesion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AFROC (time frame: 1 year). 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 NCT06068413, which also lists 1 linked publication.
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 10 Feb 2025.