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临床试验/NCT04811677
NCT04811677已完成不适用

Comparison of a SegNet-based Algorithm Quantitatively Estimating Epifascial Fibrosis in Three-dimensional Computed Tomography Images to the Clinical Lymphedema Grading Method

Chungnam National University Sejong Hospital1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018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
27
试验地点
1
主要终点
accuracy

研究概览

简要总结

To approval for detecting lymphedema fibrosis before its progression, verification of CT-based quantification of suprafascial microscopic fibrosis has been tried.

详细描述

In lymphedema, proinflammatory cytokine-mediated progressive cascades always occur, leading to macroscopic fibrosis. However, no methods are practically available for measuring lymphedema-induced fibrosis before its deterioration. Technically, CT can visualize fibrosis in superficial and deep locations. For standardized measurement, verification of deep learning (DL)-based recognition was performed. A cross-sectional, observational cohort trial was conducted at a teaching university hospital. The protocol of this study was approved by the University Hospital Institutional Review Board and was registered at the Protocol Registration and Results System (PRS), www. clini caltr ials. gov (NCT04811677: https:// clini caltr ials. gov/ ct2/ show/ NCT04 811677? term= NCT04 81167 7& draw= 2& rank=1). All methods were performed in accordance with the relevant guidelines and regulations. The trial conformed to the tenets of the Declaration of Helsinki. Patients were included if they were clinically diagnosed with unilateral limb lymphedema and had undergone BEI analysis and CT scanning. The subjects provided written informed consent for publication of the case details. Data were collected as close to the CT scanning date as possible. Patients who were diagnosed with deep vein thrombosis, bilateral limb involvement, vascular disease, or local infection were excluded.

After narrowing window width of the absorptive values in CT images, SegNet-based semantic segmentation model of every pixel into 5 classes (air, skin, muscle/water, fat, and fibrosis) was trained (65%), validated (15%), and tested (20%). Then, 4 indices were formulated and compared with the standardized circumference difference ratio (SCDR) and bioelectrical impedance (BEI) results. In total, 2138 CT images of 27 chronic unilateral lymphedema patients were analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •The patients who were clinically diagnosed with unilateral limb lymphedema and who underwent multi-frequency bio-electric impedance (BEI) analysis and CT scanning.

排除标准

  • •The patients who were diagnosed with deep vein thrombosis, bilateral limbs involvement, vascular diseases or local infection were excluded.

结局指标

主要结局

accuracy

时间窗: within 1 week after CT scanning

a ratio between the correctly classified pixel and all the classified pixel in one label.

次要结局

  • First index(within 1 week after CT scanning)

研究者

发起方
Chungnam National University Sejong Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Ho Hwang, MD, PhD.

Chief director

Chungnam National University Sejong Hospital

研究点 (1)

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