Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT

Official title

Artificial Intelligence-Assisted Opportunistic Screening for Breast Cancer Using Non-Contrast Chest CT: A Comparative Study With Mammography and/or Breast MRI

Overview

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.

Detailed description

Breast cancer is one of the most common malignancies in women, and early detection is essential for improving clinical outcomes. While dedicated breast imaging modalities, including mammography and breast MRI, are widely used for screening. Many women undergo non-contrast chest CT scans for other clinical indications, providing a potential opportunity for breast evaluation. This observational study aims to investigate the clinical value of non-contrast chest CT scans as an opportunistic screening tool for breast cancer. Breast tissue visible on routine CT scans will be assessed using artificial intelligence-based methods to identify suspicious lesions. The primary objective is to evaluate the diagnostic performance of non-contrast chest CT in detecting breast cancer, including sensitivity, specificity, and accuracy, and to further compare its diagnostic performance with mammography and breast MRI. The findings are expected to determine whether non-contrast chest CT can serve as an opportunistic tool for early breast cancer detection without additional imaging burden, and to clarify its relative clinical value compared with established breast imaging techniques.

Primary outcome measures

• Screening performance of non-contrast chest CT for detection of breast cancer, with comparison to mammography and/or breast MRI [Time frame: Up to 12 months]

Secondary outcome measures (1)

• Performance of non-contrast chest CT for histological classification of breast cancer, with comparison to mammography and/or breast MRI [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

China · 1 center

• Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07557654 · FDBC-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗