AI and 3D imaging join forces to spot breast cancer faster
NCT ID NCT07491055
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether combining a special 3D mammogram (wide-angle tomosynthesis) with an AI tool helps doctors diagnose breast cancer more accurately and confidently. About 1,400 women with breast symptoms or who were called back after a screening mammogram will take part. The goal is to see if this technology reduces the need for extra tests and improves detection.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Participants will be adults receiving diagnostic breast imaging at The Ottawa Hospital Breast Imaging Center. The study population consists of consecutive patients referred for assessment of screen-detected abnormalities or clinical breast symptoms, who undergo routine diagnostic mammography performed on the Siemens MAMMOMAT B.brilliant system.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provides verbal consent to participate. * Referred for diagnostic breast imaging at The Ottawa Hospital due to: * Recall from a screening mammogram for a soft-tissue lesion, or * Breast symptoms (e.g., palpable mass, nipple discharge) with last screening mammogram \>6 months prior. * Able to undergo wide-angle DBT and Insight 2D views on the Siemens MAMMOMAT B.brilliant system. Exclusion Criteria: * Presence of breast implants. * History of breast surgery on the breast being evaluated. * Required imaging views not obtained (wide-angle DBT + Insight 2D views). * Unable or unwilling to complete the imaging procedure per standard protocol. * Declines the use of AI on the mammography unit (patients who decline are imaged on another machine and not included).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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