Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07557654 · FDBC-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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