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临床试验/NCT04068987
NCT04068987Unknown不适用

Parametric Mapping in Paediatric Magnetic Resonance Imaging

Hong Kong Children's Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2019年8月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
Parametric mapping values of normal subjects and patients

研究概览

简要总结

Magnetic resonance imaging (MRI) is increasingly an important tool for diagnosis and management of cardiac diseases in children.

One of the uses of MRI is tissue characterisation, in which the signal characteristics of the cardiac muscle (myocardium) can be determined with special techniques, known as parametric mapping.

There is increasing evidence that parametric mapping may be able to identify regions of scarring in the myocardium, or detection of oedema/inflammation in the setting. This in turn can help predict disease course and add value to the management of patients.

There is also evidence that other structures that are visualised in parametric mapping aside from the heart (e.g. liver and spleen) can also help improve diagnostic accuracy and guide management.

Currently the majority of studies describing the use of parametric mapping is focused on adults, with limited data on its use in children.

The parametric mapping values can also differ amongst different machines, so calibration with normal subjects are also required.

详细描述

Magnetic resonance Imaging (MRI) can provide tissue characterisation without radiation and need for invasive biopsy.

Parametric mapping techniques (T1 mapping, extracellular volume fraction, T2 mapping, T2* mapping) are methods of quantitative analysis of tissue properties, and are currently commercially available.

T1 mapping, extracellular volume fraction (ECV) and T2* mapping provides knowledge about the tissue properties of the myocardium, interstitium and adjacent structures,and can provide information for diagnosis of fibrosis, inflammatory and infiltrative diseases.

T2 mapping is useful for assessing oedema, which may be useful in monitoring disease activity such as myocarditis.

Parametric mapping has proven clinical utility in iron deposition, amyloid disease, Anderson-Fabry disease and myocarditis.

研究设计

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

入排标准

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

入选标准

  • Healthy volunteers
  • Paediatric patients <=18 years of age with suspected or confirmed cardiac disease undergoing clinically indicated MRI

排除标准

  • Unstable or uncooperative patients that cannot tolerate MRI
  • Patients with contraindications for MRI (e.g. patients with implanted devices that are not MRI compatible)

结局指标

主要结局

Parametric mapping values of normal subjects and patients

时间窗: through study completion, up to 2 years

Parametric mapping values are generated upon completion of the MR sequence

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth CHEUNG

Associate Consultant

Hong Kong Children's Hospital

研究点 (1)

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