Can non-contrast chest CT help screen for breast cancer alongside standard imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the feasibility and accuracy of using non-contrast chest CT scans to opportunistically screen for breast cancer. Researchers will use AI-assisted analysis of chest CTs obtained for other indications to identify suspicious breast lesions and compare diagnostic performance with conventional imaging modalities such as mammography and breast MRI. The study will measure sensitivity, specificity, and overall accuracy, and will examine how non-contrast CT findings align with pathology or long-term clinical follow-up. By leveraging existing imaging, the study aims to determine whether chest CT could add value to breast cancer screening without requiring additional scans. The investigation involves multiple institutions in China and relies on retrospective data with defined quality and timing criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Yajia Gu, MD — Fudan University
• Study coordinator: Chao You, MD
• Email: youchao@fudan.edu.cn
• Phone: +86-021-15800780035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.