Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening and Diagnosis of Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Peking University People's Hospital Radiology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243121
• Other study ID #: AI-BMRI-S
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2022
• Source: Peking University People's Hospital
• Contact: Yi Wang, doctor
• Phone: 86+010-88325813
• Email: wangyi[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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 mass in 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 with clinical symptoms (define as palpable mass, nipple discharge, asymmetric thickening or nodules, and abnormal skin changes)
• Patients undergoing full sequence BMRI examination
• 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.
• There are contraindications for breast-enhanced MRI examinations such as allergy to contrast agents.
• A prosthesis is implanted in the affected breast.
• Patients during lactation or pregnancy

Related Conditions & MeSH terms

• Breast Neoplasms
• Magnetic Resonance Imaging

Intervention

Diagnostic Test:
• MRI
undergoing enhanced MRI

Locations

Country	Name	City	State
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	Breast Cancer Screening	Compare the area under the curve of the deep learning model of the BMRI full sequence, contrast-enhanced and non-contrast-enhanced sequence in the diagnosis of breast cancer.	5 years
Secondary	The accuracy of radiologists and deep learning models	Under the conditions of BMRI full sequence, contrast-enhanced and non-contrast-enhanced sequences, compare the sensitivity, specificity, positive predictive value and negative predictive value of breast tumor detection by radiologists and deep learning models.	5 years
Secondary	Health economics	Compare the examination time, reading time and cost of BMRI full sequence, contrast-enhanced and non-contrast-enhanced sequences.	5 years