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A retrospective blind clinical trial to evaluate the safety and efficacy of an adjunct diagnostic software for focal liver lesion

A retrospective blind clinical trial to evaluate the safety and efficacy of an adjunct diagnostic software for focal liver lesion

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200057144
Enrollment
Unknown
Registered
2022-03-01
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal lesions of the liver

Interventions

Gold Standard:Consistent results after expert evaluation
Index test:Auxiliary diagnostic software for focal liver lesions

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Complete liver MR Enhancement and plain scan data; 3. The field strength of MR equipment shall not be less than 1.4T; 4. The thickness of T1 sequence layer is less than 5mm, and that of T2 sequence layer is less than 8mm.

Exclusion criteria

Exclusion criteria: 1. The image is not clear and the artifacts are serious and cannot be diagnosed; 2. History of previous liver surgery or interventional therapy; 3. Severe abnormal liver background signal due to liver cirrhosis and other reasons, leading to undiagnosed; 4. The number of focal lesions in a single case was > 10; 5. If the researcher considers it not suitable for inclusion for other reasons.

Design outcomes

Primary

MeasureTime frame
specificity;sensitivity;

Secondary

MeasureTime frame
total consistent rate;KAPPA value;positive predictive value;negative predictive value;interface friendliness;operation convenience;equipment stability;diagnosis time;

Countries

China

Contacts

Public ContactYang Zhenghan

Beijing Friendship Hospital, Capital Medical University

yangzhenghan@vip.163.com+86 13910831365

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026