CT-AI-assisted breast cancer screening / Breast Neoplasms · Interventional Study

CT-AI Breast Cancer Opportunistic Screening Health Examination Study

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for a planned prospective single-arm study evaluating a locked chest CT artificial intelligence model for opportunistic breast cancer screening in asymptomatic women. No results are reported; the study has not yet begun recruitment. Clinical value cannot be assessed until outcomes are collected and published.

What was studied

Interventional, Single Group, Open label, Screening purpose. Breast Neoplasms; Female; age from 18 Years; to 80 Years; accepts healthy volunteers. Intervention: AI-Assisted Screening Group. n = 30,000. The First Affiliated Hospital with Nanjing Medical University (location in China inferred from sponsor name; not explicitly stated in source)..

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Clinicians should monitor for results from this study, as it may provide evidence on whether AI-assisted analysis of incidental chest CTs can improve breast cancer detection in screening. Until outcomes are reported, no clinical practice change is supported.

Plain-language summary

This is a registered but not-yet-recruiting prospective single-arm implementation study with no reported results; it describes a planned evaluation of an AI screening device without efficacy or safety data.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Incremental Breast Cancer Detection Rate of CT-AI (assessed at Within 3 months after the index health examination); Sensitivity of CT-AI for Breast Cancer Detection in the Retrospective Cohort (assessed at Up to 12 months of retrospective outcome ascertainment); Overall Breast Cancer Detection Rate of Combined CT-AI and Breast Ultrasound Screening (assessed at Within 3 months after the index health examination)

DesignInterventional, Single Group, Open label, Screening purpose

PopulationBreast Neoplasms; Female; age from 18 Years; to 80 Years; accepts healthy volunteers

Sample size30,000

InterventionAI-Assisted Screening Group

SettingThe First Affiliated Hospital with Nanjing Medical University (location in China inferred from sponsor name; not explicitly stated in source).

Reported figures

Quoted from the source exactly as published.

Planned enrollment30000

Primary outcome measure 1Incremental Breast Cancer Detection Rate of CT-AI, assessed within 3 months after the index health examination

Primary outcome measure 2Sensitivity of CT-AI for Breast Cancer Detection in the Retrospective Cohort, up to 12 months of retrospective outcome ascertainment

Primary outcome measure 3Overall Breast Cancer Detection Rate of Combined CT-AI and Breast Ultrasound Screening, within 3 months after the index health examination

Clinical bottom line

Caveats

This is a registry record only; no results are reported and recruitment has not yet started.
Single-arm design lacks a control comparator; detection rates cannot be benchmarked against standard screening.
Sensitivity and specificity of the CT-AI model are not reported.
Generalizability to settings outside health examination cohorts is not established.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm prospective implementation phase; no control group or randomization.

Directness

moderate

Directly addresses breast cancer detection in screening context; outcome is clinical detection, not surrogate.

Consistency

insufficient

No results reported; consistency cannot be assessed against other evidence.

Risk of bias

insufficient

Study not yet recruiting; bias assessment impossible without methods detail and results.

Sample adequacy

moderate

Planned enrollment 30,000 participants is large; actual enrollment and analysis unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07809698). This is a study registration, not published results. Lead sponsor: The First Affiliated Hospital with Nanjing Medical University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 30000 participants (ESTIMATED). Conditions: Breast Neoplasms. Interventions: DEVICE: CT-AI-assisted breast cancer screening. Primary outcome measures: Incremental Breast Cancer Detection Rate of CT-AI , Within 3 months after the index health examination; Sensitivity of CT-AI for Breast Cancer Detection in the Retrospective Cohort , Up to 12 months of retrospective outcome ascertainment; Overall Breast Cancer Detection Rate of Combined CT-AI and Breast Ultrasound Screening , Within 3 months after the index health examination. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

CT-AI-assisted breast cancer screeningNCT07809698Breast NeoplasmsThe First Affiliated Hospital with Nanjing Medical University