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Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography

NCT03708978 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5809

Last updated 2021-07-27

No results posted yet for this study

Summary

This project aims to establish a comprehensive artificial intelligence system for detecting and qualitative diagnosing breast lesions. Mammary images will be used to construct a diagnosis method based on deep learning. The system is proposed to automatically analyze the type of mammary glands, automatically identify and mark all breast lesions on the mammography images, provide the malignancy probability judgment of the lesions, the BI-RADS classification and the clinical suggestion, and also automatically generate the structured diagnosis report.

Conditions

  • Women With Breast Cancer

Interventions

DIAGNOSTIC_TEST

mammography

When a woman comes to the clinic to receive mammography. Then a radiologist will give a BI-RADS classification after reviewing the images. If a BI-RADS 4/5 is obtained, the woman will receive pathological biopsy to ensure there is a benign or malignant lesion. If a BI-RADS 3 is obtained, the woman will be followed up by a half-year interval until two year after the first mammography. At each follow up, she will receive mammography. If a BI-RADS 4/5 is obtained at follow up, she will receive pathological biopsy; if a BI-RADS 1/2/3 is obtained at follow up, she will be followed up by a half-year interval until two year. If a BI-RADS 1/2 is obtained at the first mammography, the woman will receive a second mammography after two year. During the study period, breast examination and results will be recorded for every subject. Radiologists will give the diagnosis with and without AI support.

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Ying-Shi Sun, Professor · Peking University Cancer Hospital & Institute

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-05
Primary Completion
2020-05-04
Completion
2020-05-04

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708978 on ClinicalTrials.gov