Medical-AI trial: catching breast cancer opportunistically on chest CT with AI — compared with mammography and MRI (NCT07557654)
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 tissue visible on a chest CT taken for another purpose is tested for signs of cancer without extra dose or visits.
1The breast tissue already captured on chest CT
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.
2Opportunistic screening from existing scans
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.
3Using images already taken
Opportunistic screening does not add an examination. It uses information already lying in images taken for another purpose.
- 1A CT is taken for another purposeChest CT for lung disease, a health check, or another symptom
- 2The breast appears in itThe image includes breast tissue
- 3AI picks up the signSigns of breast cancer may be detected without extra dose or an extra visit
- 4Those missed by screening are caughtDiagnostic performance is compared against mammography and breast MRI
Mammography is the basis of breast screening, while uptake and eligibility are limited. CT captures the breast in three dimensions and may carry information mammography does not. Non-contrast CT was never designed for breast screening, however, so its performance and the effect of false positives and negatives require careful validation. The study covers 5,000 cases and is recruiting.
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?
Will mammography become unnecessary?
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.
- ClinicalTrials.gov (study record, original)
- NCT ID: NCT07557654