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Completed

NCT Number: NCT05025540

Automatic Segmentation Ultrasound-based Radiomics Technology in Diabetic Kidney Disease

Diabetic kidney disease is a common complication of diabetes and the main cause of end-stage renal disease. In this study, the investigator plan to enroll nearly 500 participant with/without DKD and to develop an automatic segmentation ultrasound based radiomics technology to differentiating participant with a non-invasive and an available way.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The People's Hospital of Yingshang, Fuyang, Anhui, China

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About this study

Ultrasound examination is a convenient, cheap and non-invasive method for kidney examination. However, the ability of conventional ultrasound to distinguish diabetic kidney disease from normal kidney is limited, and it is difficult to accurately distinguish between diabetic kidney disease and normal kidney only with the naked eye. In recent years, computer science has developed rapidly and artificial intelligence has been developing continuously. Much progress has been made in applying artificial intelligence in data analysis. Machine learning is a direction of generalized artificial intelligence, its main characteristic is to make the machine autonomous prediction and create algorithm, so as to achieve autonomous learning. kidney disease and deep learning are two different approaches in the field of machine learning. In this study, image omics and deep learning were used to analyze the images. Image omics extracts traditional image features, including shape, gray scale, texture, etc., and uses machine learning (pattern recognition) models to classify and predict, such as support vector machine, random forest, XGBoost, etc. Deep learning directly uses the convolutional network CNN to extract features, and completes classification and prediction in combination with the full connection layer, etc.

This study aims to explore the detection of diabetic kidney disease and its pathological degree based on automatic segmentation ultraound-based radiomics technology, mining of internal information of ultrasound images, and form a set of non-invasive monitoring of diabetic kidney disease complications development system, especially in primary medical institutions, has a broad clinical application prospect.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with clinical diagnosis of T2DM and DKD were enrolled.
  • patients with clear B mode ultrasound imaging in both side of kidney (left and right).
  • No missing value in the vital clinical data such as eGFR and UACR.

Exclusion criteria

  • Patients with large kidney space occupying disease such as kidney renal cyst and tumor were excluded.
  • Ultrasound images with severe shadow or incomplete kidney border were excluded.

Treatment and study plan

ultrasonic imaging

Diagnostic Test

Two-dimensional ultrasound images of the patient's kidneys were obtained by ultrasound imaging.

Primary outcomes

  1. AUC

    Time frame: 6 months

    The area under curve (AUC) of radiomics model for differentiating DKD and T2DM or high level and low level DKD patients

Secondary outcomes

  1. Miou

    Time frame: 6 months

    The mean intersection over union (Miou) of DL-based auto-segmentation in different medical centers

  2. mPA

    Time frame: 6 months

    The mean pixel accuracy (mPA) of DL-based auto-segmentation in different medical centers

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Noninvasive Detection of Diabetic Kidney Disease Based on Automatic Segmentation Ultrasound-based Radiomics Technology

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 27, 2021
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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