Clinical Trial

Human-AI Collaborative INSIGHT Diagnostic Workflow for in Breast Cancer With Extensive Intraductal Component

Study acronym: INSIGHT-EIC
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to see if an artificial intelligence (AI)-assisted method helps doctors more accurately detect invasive breast cancer in people with a specific type of tumor called "extensive intraductal carcinoma" (EIC). This type of tumor is challenging to diagnose correctly using standard methods. The main question this study aims to answer is: Does the new AI-assisted method find more invasive breast cancer in EIC tumors compared to the standard method? Researchers will compare two groups: * Group 1 (INSIGHT): Doctors review breast tissue samples using an AI tool that highlights suspicious areas needing closer attention. * Group 2 (Conventional): Doctors review breast tissue samples without AI help, using the standard method. This comparison will show if the AI-assisted method works better at finding invasive cancer. What happens in the study? * Researchers will use stored breast tissue samples already collected during the participant's surgery. * Each sample will be randomly assigned to be reviewed using either the new AI-assisted method (Group 1) or the standard method (Group 2). * In Group 1, an AI program will scan the tissue images first and point out areas that might contain invasive cancer for the doctor to check closely. * In Group 2, doctors will review the tissue images without any AI help, using their standard process. * Researchers will measure which method finds invasive cancer more accurately, how long the review takes, and how many additional tests (called IHC stains) are needed. No new procedures are required from participants; the study uses existing tissue samples.
Trial Details
NCT Number NCT07060599
Lead Sponsor Sun Yat-sen University
Conditions Artificial Intelligence (AI) in Diagnosis
Enrollment 480 participants
Start Date 2025-08-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-11