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临床试验/NCT06069921
NCT06069921已完成不适用

Ultrasound-based Deep Learning Signature and Radiomics Signature Nomogram for Diagnosis of Benign and Malignant Breast Lesions of BI-RADS Category 4 Using Intratumoral and Peritumoral Regions

Ma Zhe1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015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
400
试验地点
1
主要终点
radiomcis prediction model and the model evaluation

研究概览

简要总结

This retrospective study aimed to create a prediction model using deep learning and radiomics features extracted from intratumoral and peritumoral regions of breast lesions in ultrasound images, to diagnose benign and malignant breast lesions with BI-RADS 4 classification.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.

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

  • female patients with US-visible solid breast masses who underwent biopsy and/or surgical resection, and were classified as having BI-RADS 4 lesions in medical US reports.

排除标准

  • preoperative endocrine therapy, chemotherapy, or radiotherapy, preoperative invasive breast operation, insufficient image quality, and no pathological results.

结局指标

主要结局

radiomcis prediction model and the model evaluation

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

three radiomics models were established using the support vector machines algorithm based on features extracted from the intratumoral, peritumoral, and combined regions of the breast lesions.The models were evaluated using various metrics, including AUC, accuracy, sensitivity, specificity, PPV, and NPV

次要结局

  • deep learning prediction model and the model evaluation(Immediately evaluated after the deep learning prediction 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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