Recruiting OBSERVATIONAL NCT07557654

Medical-AI trial: catching breast cancer opportunistically on chest CT with AI — compared with mammography and MRI (NCT07557654)

Fudan University Updated 2026-06-15

An observational study evaluating the feasibility and effectiveness of using non-contrast chest CT, taken for other reasons, for opportunistic breast-cancer screening with AI, and comparing its diagnostic performance with mammography and/or breast MRI. The primary outcome is the screening performance of chest CT for breast-cancer detection versus mammography/MRI. 5,000 patients; recruiting.

Trial overview (primary data)

  • StatusRecruiting
  • ConditionsBreast Cancer
  • SponsorFudan University
  • Target enrollment5,000 participants
  • Period2026-05-06 〜 2029-05-01

Key points

  • An observational study of AI opportunistically detecting breast cancer on non-contrast chest CT taken for other reasons, with feasibility and effectiveness evaluated.
  • It compares diagnostic performance with conventional mammography and/or breast MRI. The primary outcome is that detection performance.
  • Opportunistic screening uses images taken for another purpose to catch another disease without added radiation or visits.
  • 5,000 patients; recruiting. It uses dormant image information to widen screening at low cost, appealing for cost-effectiveness and equity.
  • Non-contrast CT is not designed for breast screening; false-positive/negative impact needs validation. Not an establishment of standard-screening replacement or effectiveness.

Breast-cancer screening usually means mammography, but uptake and eligibility have limits. Meanwhile many people undergo chest CT for lung conditions, health checks, or other symptoms, and the breast is captured in those images. If AI could pick up signs of breast cancer opportunistically from such CTs done for other reasons, it might catch people who slipped through the screening net, without added radiation or visits. This is the idea of opportunistic screening.

This study evaluates opportunistic breast-cancer screening from chest CT, as an observational study.

Per the registry summary, it evaluates the feasibility and effectiveness of using non-contrast chest CT for breast-cancer screening and compares its diagnostic performance with conventional mammography and/or breast MRI. The primary outcome is the screening performance of chest CT for detecting breast cancer, including comparison with mammography and/or MRI. The size is large at 5,000, and it is recruiting.

Opportunistic screening uses the dormant information of images already taken, with AI, to widen screening at no added cost or radiation, an appealing idea for cost-effectiveness and equity. Because CT captures the breast in three dimensions, it may carry information different from mammography.

But non-contrast CT was not designed for breast screening, and its performance and the impact of false positives and negatives need careful validation. This study evaluates feasibility and performance against mammography/MRI; it does not establish replacement of standard screening or effectiveness.

Why it matters

Using the dormant information of images already taken, with AI, to widen screening at no added cost or radiation is appealing for cost-effectiveness and equity. But non-contrast CT was not designed for breast screening and false-positive/negative impact needs validation (this study evaluates feasibility and performance, not an establishment of standard-screening replacement).

FAQ

What is opportunistic screening?
Using images taken for another purpose to pick up another disease without additional radiation or visits. Here it explores whether AI can catch signs of breast cancer on chest CT.
Will mammography become unnecessary?
No. This study evaluates the feasibility and performance of opportunistic chest-CT screening against mammography/MRI; it does not establish replacement of standard screening.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Medical AI#Clinical trial#CT#Breast cancer#Cancer screening#Opportunistic screening
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