Clinical trial · Observational
Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project aims to establish a comprehensive artificial intelligence system for detecting and qualitative diagnosing breast lesions. Mammary images will be used to construct a diagnosis method based on deep learning. The system is proposed to automatically analyze the type of mammary glands, automatically identify and mark all breast lesions on the mammography images, provide the malignancy probability judgment of the lesions, the BI-RADS classification and the clinical suggestion, and also automatically generate the structured diagnosis report.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Women With Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mammography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- mammography group
- description
- women who receives mammography because of suspected breast lesion(s)
- interventionNames
- Diagnostic Test: mammography
Primary outcomes (2)
- measure
- benign-malignant diagnosis accuracy
- timeFrame
- from the first mammography to pathological result obtained(an average of 3 weeks if mammography BI-RADS 4 or 5 obtained)
- description
- the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to pathology. If either one mammography of BI-RADS 4/5 in the first examination or during the two year' follow up examination is obtained,a pathological examination is performed, the lesion is judged benign or malignant according to pathological results.
- measure
- benign-malignant diagnosis accuracy
- timeFrame
- from the first mammography to 2-year-after mammography
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * the X-ray images of the breast were complete * the results of pathological diagnosis or more than 2 years of mammography follow-up were available * subject signs informed consent(this item was only for prospective study cases) Exclusion Criteria: * there exists pathological diagnosis of breast lesions when receiving mammography * there lacks pathological diagnosis or 2 years of mammography follow-up * subject withdraws(this item was only for prospective study cases)
References
Publications (0)
Data not yet available