RecruitingNCT07557654

Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT

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

Enrollment

5,000 participants

Start Date

May 6, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to evaluate the feasibility and effectiveness of using non-contrast chest computed tomography scans for opportunistic breast cancer screening, and to further compare its diagnostic performance with conventional imaging modalities, including mammography and/or breast magnetic resonance imaging.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

  • Female patients who have undergone non-contrast chest CT examination;
  • Participants included in the comparative analysis must have undergone at least one comparator imaging modality (mammography and/or breast MRI);
  • If a breast lesion is detected, it must be confirmed by pathology or clinical follow-up at least 12 months;
  • No prior systemic or local therapy before imaging examinations;
  • Imaging data are complete and of sufficient quality for analysis.

Exclusion Criteria5

  • History of other malignancies with potential impact on breast imaging interpretation;
  • Participants with suspected malignant breast lesions but no confirmation;
  • Prior radiotherapy, chemotherapy, or immunotherapy before imaging examinations;
  • Imaging data that are incomplete, of poor quality, or contain significant artifacts preventing reliable analysis;
  • 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.

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Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07557654


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