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临床试验/NCT06591481
NCT06591481已完成不适用

Retrospective Case-control Study for the Development of an Artificial Intelligence (AI)-Based Tool of Lesion Detection Based on Magnetic Resonance Imaging (MRI) and Clinical Variables for Early Diagnosis of Axial Spondyloarthritis (axSpA)

Ángel Alberich Bayarri7 个研究点 分布在 4 个国家目标入组 925 人开始时间: 2023年2月19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
925
试验地点
7
主要终点
Area Under the Curve (AUC)

研究概览

简要总结

The goal of this observational study is to develop and validate an Artificial Intelligence (AI) tool that allows the lesion detection and early diagnosis of axial spondyloarthritis (axSpA) based on Magnetic Resonance Imaging (MRI).

This study will gather MRI scans from axSpA patients and a control group of participants.

详细描述

BACKGROUND

The spondyloarthritis (SpA) are a group of chronic inflammatory diseases of autoimmune nature that share common clinical and genetic features, including an association with HLA-B27 antigen. They are among the most common rheumatic diseases with a prevalence of 0.01-2,5%. All of these conditions make the patients to move on a chronic disabling disease.

Patients with SpA can be classified based on their clinical presentation into either predominantly axial SpA (axSpA) or predominantly peripheral SpA. Axial SpA is characterized by primary involvement of the sacroiliac joints (SIJs) and/or the spine, leaading to substantial pain and disability. Until recently, the diagnosis of axSpA relied on detecting of structural changes evocative of sacroiliitis in the SIJs using plain radiography.

The introduction of Magnetic resonance imaging (MRI) for evaluating the SIJs has significantly advanced the recognition of axSpA. MRI can detect early inflammatory processes even in patients who do not yet have structural lesions. Besides, MRI has shown superiority over radiography in detecting structural changes in the SIJs. However, the definition of a "positive MRI" in SpA remains controversial, as both sensitivity and specificity have their limitations. Early diagnosis of SpA has become increasingly important, as treatments are now available, and MRI is emerging as the preferred choice for early diagnosis. A number of randomized controlled trials of anti-tumour necrosis factor agents in ankylosing spondylitis have demonstrated regression of inflammatory lesions in the spine by MRI. Moreover, the role of MRI in the early diagnosis of SpA has become better established, and imaging features of active sacroiliitis by MRI have been defined for axSpA diagnosis.

RATIONALE OF THE STUDY

研究设计

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

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Another known pathology in the SIJ which may influence the MRI interpretation.
  • Unreadable MRI images or with insufficient diagnostic quality.

结局指标

主要结局

Area Under the Curve (AUC)

时间窗: From diagnosis until sample completion (an average of 2 years)

The metric used for parameter optimization and model selection will be the area under the curve (AUC) for balanced dataset.

F1 score

时间窗: From diagnosis until sample completion (an average of 2 years)

In case of unbalanced dataset, F1 score will be used for parameter optimization and model selection.

Balanced accuracy

时间窗: From diagnosis until sample completion (an average of 2 years)

Matthews correlation coefficient

时间窗: From diagnosis until sample completion (an average of 2 years)

Sensitivity

时间窗: From diagnosis until sample completion (an average of 2 years)

Specificity

时间窗: From diagnosis until sample completion (an average of 2 years)

次要结局

未报告次要终点

研究者

发起方
Ángel Alberich Bayarri
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Ángel Alberich Bayarri

CEO and co-founder of Quibim

Quibim

研究点 (7)

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