Skip to main content
OpenTrials
Completed

NCT Number: NCT04811677

Comparison of a SegNet-based Algorithm Estimating Epifascial Fibrosis

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungnam National University Sejong Hospital

Sejong, 30099, South Korea

About this study

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.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Radiology

Other

image analysis

Primary outcomes

  1. accuracy

    Time frame: within 1 week after CT scanning

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

Secondary outcomes

  1. First index

    Time frame: within 1 week after CT scanning

    (P_(Fat in Affected)+P_(Fibrosis in Affected))/(P_(Fat in Unaffected)+P_(Fibrosis in Unaffected) ) " "

Sponsors and collaborators

Lead sponsor

Chungnam National University Sejong Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2021
Registry last updated
Dec 20, 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.

Published trials that share one or more normalized conditions with this study.