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Recruiting
NCT07557654
Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 5000
Sponsor: Fudan University
Location: Fudan University Shanghai Cancer Center Shanghai
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 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.
Source: ClinicalTrials.gov (NCT07557654). StuddyBuddy aggregates publicly available trial information.