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Retrospective, multi-center, multi-reader, multi-case(MRMC) clinical trial to evaluate the effectiveness of auxiliary diagnosis software for focal liver lesions

Retrospective, multi-center, multi-reader, multi-case(MRMC) clinical trial to evaluate the effectiveness of auxiliary diagnosis software for focal liver lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062987
Enrollment
Unknown
Registered
2022-08-26
Start date
2022-08-29
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

focal liver lesion

Interventions

Gold Standard:In this study, consistent assessing results from expert evaluation for focal liver lesions.
adjunct&#32
diagnostic&#32
for&#32
lesion

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Case inclusion criteria: 1) =18 years; 2) Complete liver enhancement and plain MR images; 3) The field intensity of MR equipment shall not be less than 1.4T; 4) Slice thickness of T1WI sequence =5mm,5mm=slice thickness of T2WI sequence=8mm.If the case is positive, a benign or malignant diagnosis result that meets the criteria for diagnosis and treatment of pathology or clinical routine diagnosis and treatment is also required. 2)Candidate inclusion criteria: 1) minimum 1 year of imaging work experience(considering different seniority); 2) have a practicing physician qualification certificate; 3) have a GCP certificate.

Exclusion criteria

Exclusion criteria: 1) The image is not clear or the artifact is too serious to be diagnosed; 2) History of liver surgery or interventional therapy; 3) The liver background signal is seriously abnormal due to cirrhosis or other reasons, leading to undiagnosis; 4) The number of focal lesions in a single case was more than 10; 5) Those that the investigator considers inappropriate for other reasons.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;AFROC-AUC;

Secondary

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

Countries

China

Contacts

Public ContactZhenghan Yang

Beijing Friendship Hospital, Capital Medical University

yangzhenghan@vip.163.com13910831365

Outcome results

None listed

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