Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women

Breast Cancer Clinical Trial

Official title:

Peking University People's Hospital Breast Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04996615
• Other study ID #: AI-BMRI
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Magnetic Resonance Imaging

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