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临床试验/NCT06158776
NCT06158776已完成不适用

Research on the Prediction and Mechanism of Rectal Adenoma Canceration Based on Radiomics of Multimodal MRI Combined With Clinical Indicators

Aiyin Li1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022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
100
试验地点
1
主要终点
IVIM parameter

研究概览

简要总结

In this retrospective study is to establish a diagnostic model for rectal adenoma canceration. The model will include multimodal comprehensive HR-T2WI morphological score, IVIM functional imaging and radiomics features, and clinical indicators such as tumor markers, serum Gelsolin protein and peripheral blood inflammatory cell ratio. It can be to provide accurate diagnostic information for patients before surgery, which is of great value for formulating personalized treatment plans and improving the prognosis of patients.

详细描述

Imaging tests is the main method for evaluating rectal mass, especially MRI, which has been widely used in the preoperative diagnosis of rectal mass disease due to its very good soft tissue resolution. Previous studies in our group found that HR-T2WI-based radiomics, HR-T2WI-based morphology, and IVIM-based functional imaging can be used for the diagnosis of adenoma canceration. In addition to imaging, other tests, such as peripheral blood tests, can also reflect the development and progression of adenocarcinoma by counting tumor markers (colorectal tumor markers mainly CEA, AFP, CA199, CA724, CA50, CA242), inflammatory cell ratio (lymphocyte/C-reactive protein ratio, neutrophil/lymphocyte ratio, lymphocyte/monocytes ratio), and special types of proteins (such as coagulant protein).This study identifies the progression of adenoma to carcinoma by analyzing the combined cellular, morphological, and functional changes in adenoma carcinomas, with the expectation that multimodal co-diagnosis will improve the accuracy of clinical diagnosis.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • surgical resection
  • pathologically confirmed rectal adenoma or rectal adenoma with canceration
  • rectal MRI examination including IVIM-DWI, within two weeks before surgery

排除标准

  • preoperative treatment
  • poor image quality, including intestinal gas or fecal artifact and IVIM image fitting error
  • no surgical resection but colonoscopy
  • pathologically confirmed rectal cancer.

结局指标

主要结局

IVIM parameter

时间窗: 10-15 minutes

IVIM sequence images were analyzed using Functool MADC software, and the region of interest (ROI) was placed in the solid region of the tumor, continuously outlining the edges of the hypertensive lesions. The D, D, and F values of the lesion are then measured and recorded.

Radiomics score

时间窗: 10-15 minutes

Tumor volume is manually sketched as ROI by RadCloudv2.2 platform on HR-T2WI images. Three sets of features were extracted based on VOI, and then the screened feature values were scored using software R.

morphological scoring based on HR-T2WI

时间窗: 5-10 minutes

Radiologists interpret the lesion according to the performance of HR-T2WI, and the interpretation criteria are whether the mucosal layer signal is continuous, whether the intestinal wall is wrinkled, and whether the tumor has external convexity.

Clinical indicators

时间窗: 3-7 minutes

The levels of tumor markers and inflammatory cell indexes of all patients in this study were collected, and meaningful indicators were statistically analyzed as one of the identification items. Tumor markers mainly include CEA, AFP, CA199, CA724, CA50 and CA242,inflammatory cell ratios include lymphocyte/C-reactive protein ratio, neutrophil/lymphocyte ratio and lymphocyte/monocytes ratio, in addition to special types of proteins (such as coagulant protein).

次要结局

  • Nomogram(10-20 minutes)

研究者

发起方
Aiyin Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aiyin Li

professor

Qianfoshan Hospital

研究点 (1)

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