Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

5,809

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach

1 country

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

April 5, 2018

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed

6 months until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed

Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

April 17, 2018

Last Update Submit

July 24, 2021

Conditions

Women With Breast Cancer

Outcome Measures

Primary Outcomes (2)

benign-malignant diagnosis accuracy
the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to pathology. If either one mammography of BI-RADS 4/5 in the first examination or during the two year' follow up examination is obtained,a pathological examination is performed, the lesion is judged benign or malignant according to pathological results.
from the first mammography to pathological result obtained(an average of 3 weeks if mammography BI-RADS 4 or 5 obtained)
benign-malignant diagnosis accuracy
the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to follow up. If a 2-year mammography of BI-RADS 1/2/3 is obtained, the lesion is considered benign. If either one mammography of BI-RADS 4/5 during the two year is obtained,a pathological examination is performed to ensure the benign or malignant lesion
from the first mammography to 2-year-after mammography

Secondary Outcomes (1)

lesion detection accuracy
from the first mammography to radiologist diagnosis (within 3 days after the mammography taken)

Study Arms (1)

mammography group

women who receives mammography because of suspected breast lesion(s)

Diagnostic Test: mammography

Interventions

mammographyDIAGNOSTIC_TEST

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.

mammography group

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Women with suspected Breast Lesion

You may qualify if:

the X-ray images of the breast were complete
the results of pathological diagnosis or more than 2 years of mammography follow-up were available
subject signs informed consent(this item was only for prospective study cases)

You may not qualify if:

there exists pathological diagnosis of breast lesions when receiving mammography
there lacks pathological diagnosis or 2 years of mammography follow-up
subject withdraws(this item was only for prospective study cases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking University Cancer Hospital & Institutelead
Peking Universitycollaborator

Study Sites (8)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Chao Yang Women and Children's Health Hospital