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

Peking University People's Hospital Radiology

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05243121
Enrollment
5000
Registered
2022-02-16
Start date
2022-02-28
Completion date
2025-09-30
Last updated
2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Magnetic Resonance Imaging

Keywords

breast neoplasms, magnetic resonance imaging, screening, deep learning, machine learning

Brief 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.

Interventions

DIAGNOSTIC_TESTMRI

undergoing enhanced MRI

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Breast Cancer Screening5 yearsCompare 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.

Secondary

MeasureTime frameDescription
The accuracy of radiologists and deep learning models5 yearsUnder 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.
Health economics5 yearsCompare the examination time, reading time and cost of BMRI full sequence, contrast-enhanced and non-contrast-enhanced sequences.

Countries

China

Contacts

Primary ContactYi Wang, doctor
wangyi@pkuph.edu.cn86+010-88325813

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026