Artificial Intelligence-Assisted Opportunistic Screening for Breast Cancer Using Non-Contrast Chest CT: A Comparative Study With Mammography and/or Breast MRI
Sponsor: Fudan University
Trial Details
| Condition | Breast Cancer |
| Status | Recruiting |
| Participants | 5,000 |
| Est. Completion | 1 May 2028 |
| Last Updated | 15 June 2026 |
Primary Outcome
Screening performance of non-contrast chest CT for detection of breast cancer, with comparison to mammography and/or breast MRI
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: 1. Female patients who have undergone non-contrast chest CT examination; 2. Participants included in the comparative analysis must have undergone at least one comparator imaging modality (mammography and/or breast MRI); 3. If a breast lesion is detected, it must be confirmed by pathology or clinical follow-up at least 12 months; 4. No prior systemic or local therapy before imaging examinations; 5. Imaging data are complete and of sufficient quality for analysis. Exclusion Criteria: 1. History of other malignancies with potential impact on breast imaging interpretation; 2. Participants with suspected malignant breast lesions but no confirmation; 3. Prior radiotherapy, chemotherapy, or immunotherapy before imaging examinations; 4. Imaging data that are incomplete, of poor quality, or contain significant artifacts preventing reliable analysis; 5. Time interval between non-contrast chest CT and comparator imaging modalities exceeding three months, or with clinical events occurring between examinations that may alter lesion status.
Trial Sites
Countries
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