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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04996615
Other study ID # AI-BMRI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 30, 2025

Study information

Verified date November 2022
Source Peking University People's Hospital
Contact shu wang, doctor
Phone 86+010-88324010
Email shuwang@pkuph.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Use Convolutional Neural Networks Analysis for Classification of Contrast-enhancing Lesions at Multiparametric Breast MRI. Build an abbreviated protocal, and investigate whether an abbreviated protocol was suitable for breast magnetic resonance imaging screening for breast cancer in high-risk Chinese women, which can shorten the examination time and avoid enhanced imaging while ensuring the accuracy of the diagnosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Patients undergoing full sequence BMRI examination - Written informed consent and complete the clinical data questionnaire - Through the follow-up database, at least 6 months of follow-up results can be obtained to determine whether the diagnosis result is negative/benign/malignant; for patients who need pathological biopsy, the pathological biopsy results shall prevail to determine the lesion benign/malignant. Exclusion Criteria: - The breast had received radiotherapy, chemotherapy, biology and other treatments before BMRI. - Signs or symptoms of breast disease - There are contraindications for breast-enhanced MRI examinations such as allergy to contrast agents. - Patients during lactation or pregnancy

Study Design


Intervention

Other:
no intervention
no intervention

Locations

Country Name City State
China Peking university people's hospital Beijing Bei Jing
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary screening yield compare the rates of detection of breast cancers in the screening of high-risk populations between the Breast MRI full sequence, contrast-enhanced and non-contrast-enhanced sequence. 5 years
Secondary The accuracy of radiologists and deep learning models compare the sensitivity,specificity, positive predictive value and negative predictive value of breast tumor detection by radiologists and deep learning models. 5 years
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