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A Diffusion-weighted MRI-based artificial intelligence model assisted in the diagnosis of breast lesions:A multireader, multicase trail

A Diffusion-weighted MRI-based artificial intelligence model assisted in the diagnosis of breast lesions:A multireader, multicase trail

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095953
Enrollment
Unknown
Registered
2025-01-15
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Benign and malignant lesions of the breast including adenosis of breast, fibroadenoma, atypical hyperplasia, intraductal papilloma, ductal carcinoma in situ, and invasive breast cancer.

Interventions

Gold Standard:Core biopsy results or postoperative pathological findings
Index test:Diffusion-weighted MRI-based artificial intelligence model

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Complete breast MRI data; 2. Negative pathology biopsy results or negative follow-up examinations for at least 12 months for non-cancer cases; 3. Positive biopsy results that meet the requirements for the pathological subtype of cancer for cancer cases; 4. Original data that can be used to verify clinical status, including radiological and pathological reports;

Exclusion criteria

Exclusion criteria: 1. Partial mastectomy or puncture biopsy on the diseased side of the breast prior to breast MRI examination; 2. Poor image quality; 3. Implants in the affected breast;

Design outcomes

Primary

MeasureTime frame
Area Under the Receiver Operating Characteristic;

Secondary

MeasureTime frame
Intraclass Correlation Coefficient;Sensitivity;Specificity;

Countries

China

Contacts

Public ContactYi Wang

Peking University People's Hospital

wangyi@pkuph.edu.cn+86 10 88325813

Outcome results

None listed

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