跳至主要内容
临床试验/NCT06095414
NCT06095414已完成不适用

Prospective Study of MRI-based Radiomics in Breast Cancer

Korea University Ansan Hospital1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
121
试验地点
1
主要终点
The signal intensity of Magnetic Resonance Images for tumor microenvironment

研究概览

简要总结

The goal of this prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer.

The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on MRI of participants with invasive breast cancer before treatment.

详细描述

The written informed consents for the participation into this prospective study is done in participants who are diagnosed with invasive breast cancer before surgery with curative intent. After enrollment, breast MRI is done for particpants and diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images are extracted from the results of MRI of participants. The tumor tissue samples are archived from participants before surgery through core-needle biopsy and the immunohistochemistry is done to assess the components of tumor microenvironment including intraturmoal and peritumoral components through volume histochemical assessment. Radiomic feature selection and prediction model building are performed using the least absolute shrinkage and selection operator and linear regression analysis, respectively. The investigators apply fivefold cross-validation to prevent overfitting, and the performance is evaluated using the area under the receiver operating characteristic curve (AUC) and the DeLong test.

研究设计

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

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with invaseiv breast cancer

排除标准

  • Diagnosed with other cancers

结局指标

主要结局

The signal intensity of Magnetic Resonance Images for tumor microenvironment

时间窗: Baseline, pre-surgery

The percentage of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images correlated with the percentage of immune cells infiltrating tumor microenvironment of breast tumor tissue

次要结局

未报告次要终点

研究者

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

Bo Kyoung Seo

Professor

Korea University Ansan Hospital

研究点 (1)

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