Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)
Evaluation of Morphological and Functional Magnetic Resonance Imaging (MRI) for Early Diagnosis of Lung Changes in Children (0-6 Years) With Cystic Fibrosis (CF)
In patients with Cystic Fibrosis (CF) the clinical course of lung disease is crucial for individual prognosis and life expectancy.
Imaging modalities are important in the assessment of follow up of structural lung changes and monitoring of pulmonary complications in CF. Although high resolution computed tomography (HRCT) is the accepted gold standard for evaluation of morphological lung changes in CF, chest-X-ray is widely used as standard imaging procedure for assessment and follow up in these young patients due to less radiation exposure.
Magnetic resonance imaging (MRI) has not been used for lung imaging in CF so far. Studies from the 80's and early 90's were not able to show any impact for the use of MRI in CF. Due to recent technical developments MRI of the lung became possible.
Our study group was able to show that MRI is a competitive imaging modality for evaluating changes of the CF-lung in comparison to the gold standard (HRCT).
So far only patients from the age of 6-7 years were examined. According to recent studies CF is a disease which starts in utero. Therefore it can lead to extensive pulmonary changes even in infants and young children. In this age group lung function testing is difficult and not broadly available. An early optimized therapy is crucial for the long term course and outcome of the pulmonary disease.
The aim of this study is to evaluate morphological and functional MRI for early diagnosis of lung changes in children (0-6 years) with CF.
研究概览
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
-
Heidelberg、德国、69120
- German Cancer Research Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Informed consent signed by the parents or a legal guardian
- Sedation as necessary
- Conventional clinical indicated diagnostic procedures (lung function test, chest-X-ray, CT)
Exclusion Criteria:
Study exclusion in case of contra indications for MRI:
- Patients with cardiac pace maker, metallic implants (e.g. cerebral vessel clips) as well as other conditions that prohibit the exposition of a patient to a strong magnetic field.
- No informed consent
- Dyspnea, which disables the patient to follow breathing instructions during the study.
学习计划
研究是如何设计的?
设计细节
- 观测模型:案例交叉
- 时间观点:预期
队列和干预
团体/队列 |
|---|
|
1CF-patients<6
Patients with diagnoses of cystic fibrosis from birth to the age of 6 years
|
|
2 controls
age matched controls
|
合作者和调查者
调查人员
- 首席研究员:Michael Puderbach, MD、German Cancer Research Center
出版物和有用的链接
一般刊物
- Sommerburg O, Wielputz MO, Trame JP, Wuennemann F, Opdazaite E, Stahl M, Puderbach MU, Kopp-Schneider A, Fritzsching E, Kauczor HU, Baumann I, Mall MA, Eichinger M. Magnetic Resonance Imaging Detects Chronic Rhinosinusitis in Infants and Preschool Children with Cystic Fibrosis. Ann Am Thorac Soc. 2020 Jun;17(6):714-723. doi: 10.1513/AnnalsATS.201910-777OC.
- Wielputz MO, Puderbach M, Kopp-Schneider A, Stahl M, Fritzsching E, Sommerburg O, Ley S, Sumkauskaite M, Biederer J, Kauczor HU, Eichinger M, Mall MA. Magnetic resonance imaging detects changes in structure and perfusion, and response to therapy in early cystic fibrosis lung disease. Am J Respir Crit Care Med. 2014 Apr 15;189(8):956-65. doi: 10.1164/rccm.201309-1659OC.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.