Functional Magnetic Resonance Imaging of the Lung to Detect Regional Reversibility and Progression in Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Identification of ILD Subtypes Using Baseline MRI Metrics
研究概览
简要总结
The main objective of this study is to investigate the utility of functional MRI to differentiate, characterize, and monitor subgroups of ILD. This can be broken down into three specific objectives:
Determine if ILD features observed on high-resolution computed tomography (HRCT), such as ground glass opacities (GGO), are functionally different.
Analyse MRI metrics within each subgroup to determine whether these metrics distinguish different ILDs.
Assess MRI metrics longitudinally to see if these parameters change with disease progression, stability, or reversibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical indication for a routine HRCT because of either newly diagnosed idiopathic pulmonary fibrosis (IPF) or hypersensitivity pneumonitis (HP) or idiopathic non-specific interstitial pneumonia (iNSIP), suspected diagnosis, or follow-up
- •Capacity to consent
- •Ability to participate fully in the study (defined by the ability to lie still for the duration of imaging)
排除标准
- •Pregnancy and breast feeding
- •Persons under the age of 18 and persons not able to give informed consent
- •Any medical conditions that could hinder the ability to adhere to the protocol
- •Any MRI contraindication, including previous allergic reactions to Gd-based MRI contrast material and renal dysfunction (eGFR < 30 ml min/1,73 m2)
结局指标
主要结局
Identification of ILD Subtypes Using Baseline MRI Metrics
时间窗: Baseline (first MRI scan)
Assess whether baseline MRI metrics can accurately differentiate subtypes of interstitial lung disease, using clinician diagnosis (based on multidisciplinary discussion) as the reference standard.
次要结局
- Correlation of Longitudinal MRI Changes with Disease Progression(From enrollment (baseline MRI) through up to 1-year after enrollment; follow-up assessments will only be performed if clinically indicated.)
研究者
Hans-Ulrich Kauczor
Medical Director of Diagnostic and Interventional Radiology at the Heidelberg University Hospital
University Hospital Heidelberg