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临床试验/NCT05159323
NCT05159323Unknown不适用

Quantitative Parameters of Diffusion Spectrum Imaging: Correlation With Histopathologic Characteristics in Patients With Breast Cancer

Xiang Zhang1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2021年8月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
64
试验地点
1
主要终点
Pathologic characteristic

研究概览

简要总结

This project intends to prospectively collect patients with suspected breast malignant tumors by ultrasound or mammography. After routine MRI scanning, all patients underwent diffusion spectrum imaging (DSI) sequence scanning. The inclusion criteria were as follows: (1) breast cancer was confirmed by surgery or biopsy. (2) pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer. (3) routine MRI and DSI scans were performed within one week before the pathologic examination. The exclusion criteria were as follows: (1) patients who had received treatment before DSI scanning; (2) patients who underwent breast tumor biopsy within two weeks before DSI image acquisition; (3) pathology results of breast masses were other diseases besides breast cancer. (4) post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.

Breast MRI data were collected on a 3T MR scanner (Magnetom skyra, Siemens Healthcare, Erlangen, Germany). All participants used standardized breast MRI scanning schemes, including T2 weighted imaging (T2WI), T1 weighted imaging (T1WI), diffusion-weighted imaging (DWI), DSI, and contrast dynamic enhancement (DCE). A total of 22 GSI quantitative parameters were derived from NeudiLab software that is based on the open-source platform DIPY (diffusion imaging in Python, http://nipy.org/dipy). The correlation between DSI quantitative parameters and pathological indexes (i.e., ER, PR, HER-2, Ki-67, and LVI) was evaluated by Spearman correlation analysis. The independent predictors of GSI quantitative parameters for different pathologic characteristics discrimination in breast cancer were determined by the logistic regression analysis. The predictive performance of DSI quantitative parameters for difference pathologic classifications was assessed by the receiver operating characteristic (ROC) curves and their respective area under the curves (AUCs).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Breast cancer was confirmed by surgery or biopsy.
  • Pathologically diagnosis of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor 2 (HER-2), Ki-67, and lymphatic vessel invasion (LVI) status in breast cancer.
  • Routine MRI and DSI scans were performed within one week before the pathologic examination.

排除标准

  • Patients who had received treatment before DSI scanning.
  • Patients who underwent breast tumor biopsy within two weeks before DSI image acquisition.
  • Pathology results of breast masses were other diseases besides breast cancer.
  • Post-processing of DSI data cannot be performed due to poor image quality, such as motion artifacts.

研究组 & 干预措施

Diffusion Spectrum Imaging

Experimental

All participants accept diffusion spectrum imaging, the quantitative parameters of the diffusion spectrum imaging are obtained. The quantitative parameters are compared in different subgroups based on the pathologic examination results.

干预措施: Diffusion Spectrum Imaging (Diagnostic Test)

结局指标

主要结局

Pathologic characteristic

时间窗: Up to 2 months

Estrogen receptor (ER) status of breast cancer

次要结局

  • Pathologic characteristic(Up to 2 months)

研究者

发起方
Xiang Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xiang Zhang

Department of Radiology

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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