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临床试验/NCT06497023
NCT06497023已完成不适用

Multi-modality Radiomics Diagnostic Model Based on DCE-MRI and Ultrasound Images for Benign and Malignant Breast Lesion Classification

Ma Zhe1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
550
试验地点
1
主要终点
Accuracy of different diagnostic models

研究概览

简要总结

To develop and compare multi-modality radiomics models based on DCE-MRI, B-mode ultrasound (BMUS) and strain elastography (SE) images for classifying benign and malignant breast lesions.

详细描述

In this retrospective study,555 breast lesions from 555 patients who underwent DCE-MRI, BMUS and SE examinations were randomly divided into training (n =388) and testing (n = 167) datasets. Radiomics features were extracted from manually contoured images. The inter-class correlation coefficient (ICC), Mann-Whitney U test and the least absolute shrinkage and selection operator (LASSO) regression was applied for feature selection and radiomics signature building.Nine radiomics models including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS), and the combination diagnostic model(clinical features and DCE-3D+SE+BMUS features) were developed and evaluated by their discrimination, calibration, and clinical usefulness.

研究设计

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

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with breast lesions underwent biopsy or surgical resection between January 1, 2018 and March 30, 2024.

排除标准

  • pathologicalresult of biopsy or surgical specimen was unavailable for the target lesion;
  • patients without DCE-MRI, BMUS and SE examinations before biopsy or surgery within one month;
  • patients hadperformed radiotherapy, chemotherapy, or breast biopsy before MRI and ultrasound examinations;
  • patients without completeDICOM data for each examination;
  • patients with poor-qualityimages.

结局指标

主要结局

Accuracy of different diagnostic models

时间窗: Immediately evaluated after the radiomcis diagnostic model was built

The accuracy of nine diagnostic models, including four single-modality radiomics models (DCE-3D, DCE-2D, BMUS, and SE), four multi-modality radiomics models (BMUS + SE, DCE-3D + BMUS, DCE-3D + SE, and DCE-3D+SE+BMUS),and the combination diagnostic model is the ratio of the sum of True Positive and True Negative to the total of True Positive, True Negative, False Positive, and False Negative.

次要结局

  • Sensitivity of different diagnostic models(Immediately evaluated after the radiomcis diagnostic model was built)

研究者

发起方
Ma Zhe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ma Zhe

Director of Ultrasound

Qianfoshan Hospital

研究点 (1)

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