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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Screening performance of non-contrast chest CT for detection of breast cancer, with comparison to mammography and/or breast MRI — Up to 12 months The primary outcome is the screening performance of AI-assisted analysis for the detection of breast cancer on non-contrast chest CT. The detection process is conducted in a stepwise approach, involving lesion identification followed by classification into benign or malignant categories for breast cancer detection. Performance metrics include sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and area under the receiver operating characteristic curve. Participants included in the comparative analysis must have undergone at least one comparator imaging modality (mammography and/or breast MRI) within three months of the chest CT examination, with no intervening clinical events. Performance metrics will be further compared with those obtained from mammography and/or breast MRI within the same participants to evaluate the relative screening performance.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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