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CompletedNCT05025540Updated Feb 16, 2022

Automatic Segmentation Ultrasound-based Radiomics Technology in Diabetic Kidney Disease

An observational study in Diabetic Kidney Disease, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
499
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Diabetic Kidney Disease

Keywords

  • diabetic kidney disease
  • ultrasound
  • radiomics
  • deep learning
  • multi-center
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 499 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  1. patients with diabetes
  2. patients with or without DKD

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
499 participants (actual)
Patient registry
No

Groups and cohorts

  • Experimental group

    Experimental group1:DKD patients with Type 2 diabetes patients with DKD Experimental group2:High level DKD patients with diabetic kidney disease Stage III and IV.

    Diagnostic Test: ultrasonic imaging

  • Control group

    Control1:T2DM patients with Type 2 diabetes Control2:Low level DKD patients with diabetic kidney disease Stage I and II.

    Diagnostic Test: ultrasonic imaging

Interventions

  • Diagnostic testultrasonic imaging

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

06

What researchers measure

Primary outcomes

  1. AUC

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

    Time frame: 6 months

Secondary outcomes

  1. Miou

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

    Time frame: 6 months

  2. mPA

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

    Time frame: 6 months

07

Study locations

3 sites
  • The People's Hospital of Yingshang
    Fuyang, Anhui 236200, China
  • Tianjin Third Central Hospital
    Tianjin, Tianjin 300000, China
  • Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05025540
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Aug 27, 2021
Start date
Jun 1, 2021
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Last update
Feb 16, 2022

Study contacts

Pintong Huang
study chair · Department of Ultrasound, The Second Affiliated Hospital of Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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