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AI-Assisted opportunistic breast cancer screening using non-contrast chest CT in women undergoing health examination: a retrospective validation and prospective Single-Arm interventional study

NCT ID NCT07809698

NEW Sponsor: The First Affiliated Hospital with Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This study evaluates the clinical utility of a locked chest CT artificial intelligence model for opportunistic breast cancer screening among women undergoing health examinations. The study includes a retrospective validation phase and a prospective single-arm implementation phase. AI analyzes existing non-contrast chest CT images without additional CT examinations. Clinical physicians make further evaluation decisions based on AI outputs, imaging findings, ultrasound results and clinical information.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

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.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Female participants aged 18 to 80 years. * Undergoing routine health examination. * For the prospective phase, no clear ongoing breast-related symptoms at baseline. * Availability of complete non-contrast chest CT images. In the prospective phase, chest CT must have been scheduled as part of the routine health examination or for another established clinical purpose and must not be performed solely for this study. * Availability of a contemporaneous routine breast ultrasound report and relevant clinical information. * Chest CT image quality adequate for AI analysis. * Availability of an appropriate follow-up pathway through hospital records, pathology systems, cancer registry data, or approved follow-up methods. * For the prospective phase, study information has been provided through an ethics-approved process and the participant has not actively opted out. Exclusion Criteria: * Previous diagnosis of breast cancer, prior treatment for breast malignancy, or breast malignancy already confirmed before baseline. * Pregnancy or breastfeeding. * Incomplete breast coverage on chest CT, severe image artifacts, missing images, or other conditions that prevent valid AI analysis. * Critical baseline or outcome data are substantially incomplete and cannot reasonably be recovered. * No effective follow-up pathway can be established. * For the prospective phase, the participant actively opts out before AI analysis or explicitly declines use of imaging and clinical data for this study.

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Conditions

The condition(s) this trial relates to.

breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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