2022-502512-36-00招募中2 期
Hyperpolarized 129-Xenon MRI in Fibrosing Interstitial Lung Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- MR xenon ventilation and dissolved parameters
研究概览
简要总结
This project aims to investigate the potential of non-invasive imaging to identify and monitor the earliest signs and physiological effects of pulmonary fibrosis and resulting cardiac dysfunction in patients with fibrosing interstitial lung disease. Second, to evaluate baseline risk factors the progression and therapeutic responses to anti-fibrotic drugs.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with IPF or fibrotic ILD who fulfills PPF criteria, and are prescribed antifibrotic treatment.
- •Cognitively able to understand and participate in the study
- •Pre-menopausal women must be confirmed non-pregnant by an onsite test.
排除标准
- •Contraindications for MRI (Pacemaker, neurostimulator or cochlear implant; Metal foreign bodies such as fragments and irremovable piercings; Unsafe medical implants (safety of heart valves, hips and the like must be confirmed); Intrathoracic clips or coils; Cardiac pacemakers; Claustrophobia; Largest circumference including arms > 160 cm)
- •Contraindications to gadolinium contrast (eGFR < 30 mL/min/1.73m2; Previous adverse reactions to gadolinium)
- •Overlapping emphysematic disease where the emphysema-component outweighs the fibrosis
- •Unable to perform breath-hold of minimum 20 seconds.
- •Allergy to Xenon
- •Breast feeding
- •Evidence of ongoing respiratory infections at time of MR examinations
结局指标
主要结局
MR xenon ventilation and dissolved parameters
MR xenon ventilation and dissolved parameters
Worsening of pulmonary function test parameters
Worsening of pulmonary function test parameters
Worsening of HRCT parameters
Worsening of HRCT parameters
Worsening in patient reported symptoms
Worsening in patient reported symptoms
次要结局
- Regionally decreased perfusion
- Evidence of myocardial stran and fibrosis
- Late contrast enhancement
研究者
Mattias Kristensen
Scientific
Aarhus University
研究点 (2)
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