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临床试验/NCT05421975
NCT05421975终止不适用

EASY MRI: Evaluating Airway Sarcoidosis Pathology With MRI

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2021年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
1
主要终点
Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic.(2)

研究概览

简要总结

Sarcoidosis is a condition where inflamed cells clump together to form granulomas, which can lead to inflammation or scarring. It can affect any organ of the body, but most commonly affects the lungs. Symptoms can be highly variable, and some patients have no symptoms where as others may develop fatigue or breathlessness. The causes of sarcoidosis are poorly understood. It commonly affects adults in their 30's or 40's.

Some patients present with symptoms suggestive of involvement in the airways, such as cough. Inhalers containing steroid are commonly used, but there is a poor understanding of which patients may benefit. Part of the problem is the lack of a sensitive way of measuring these effects and knowledge of how sarcoidosis affects the airways physiologically.

The investigators would like to know more about the disease process of sarcoidosis, particularly where it involves the airways. This study will use a number of techniques in order to better understand to disease process.

In order to assess whether sarcoidosis produces changes in airway ventilation (and whether these changes are stable or change over a short time period). This pilot study aims to recruit 6 patients who will have magnetic resonance imaging (MRI) with inhaled xenon gas. During this technique, xenon and nitrogen mixture is inhaled and during a subsequent breath-hold, images of the lungs are taken. This creates a detailed view of the lung airway tree, to explore how the disease affects the airways and deeper lung tissue.

This technique will be used alongside lung function tests, commonly performed in the laboratory setting and cardiopulmonary exercise testing, to see what happens in the lungs of this group of patients when they reach peak exercise capacity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Clinical diagnosis of sarcoidosis
  • Sarcoidosis clinician diagnoses airways involvement
  • Aged 18 and above

排除标准

  • Current combustible cigarette or electronic cigarette user
  • Significant doubt over the diagnosis of sarcoidosis
  • Asthma or other airways disease, requiring regular inhaler use
  • Contraindication to MRI identified on safety questionnaire
  • Recent COVID-19 infection (lateral flow or PCR swab positive within the last 28 days) or ongoing symptoms from COVID-19

结局指标

主要结局

Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic.(2)

时间窗: 12 weeks

Ventilation Coefficient of variation (CV) - a measure of ventilation heterogeneity

Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (3)

时间窗: 12 weeks

Apparent diffusion coefficient (ADC) and mean linear intercept (LmD) - measurements of the Brownian motion of gas in the acinar airways and surrogate measures of acinar integrity.

Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (4)

时间窗: 12 weeks

Red blood cell to tissue plasma ratio (RBC:TP) - a measure of the efficiency of gas exchange across the alveoli into the blood.

Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (1)

时间窗: 12 weeks

Ventilation defect percentage (VDP) - a measure of amount of the lung which goes unventilated

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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