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Retrospective, multi-center, multi-reader, multi-case(MRMC) clinical trial to evaluate the effectiveness and safety of breast X-ray imaging-assisted detection software

Clinical trial of breast X-ray imaging-assisted detection software

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070670
Enrollment
Unknown
Registered
2023-04-19
Start date
2023-04-17
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Breast lesions

Interventions

Gold Standard:The gold standard expert group consists of three senior doctors with over 10 years of breast diagnostic experience. Each gold standard expert marks and judges all the included FFDM image
Index test:AI software assisted conditions for physicians to see

Sponsors

Tianjin Medical University Cancer Institute & Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Image providers must be females aged 18 and above; 2. The FFDM examination images must include complete four views(LCC,LMLO,RCC,RMLO); 3. Have an FFDM imaging diagnostic report.

Exclusion criteria

Exclusion criteria: 1. There are serious metal artifacts or implanted objects in the image that affect interpretation; 2. The images shows morphological changes caused by breast surgery; 3. The quality of image does not meet the diagnostic requirements; 4. Cases that the investigators deemed unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;LROC-AUC;—

Countries

China

Contacts

Public ContactHong Lu

Tianjin Medical University Cancer Institute & Hospital

honglu@tmu.edu.cn+86 22 23340123

Outcome results

None listed

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