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临床试验/NCT05243121
NCT05243121招募中不适用

Peking University People's Hospital Radiology

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2022年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Breast Cancer Screening

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Breast Cancer Screening

时间窗: 5 years

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.

次要结局

  • The accuracy of radiologists and deep learning models(5 years)
  • Health economics(5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

WangYi

Director

Peking University People's Hospital

研究点 (1)

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