Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)
NCT ID: NCT00760071
Last Updated: 2010-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2006-07-31
2009-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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1CF-patients<6
Patients with diagnoses of cystic fibrosis from birth to the age of 6 years
No interventions assigned to this group
2 controls
age matched controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Sedation as necessary
* Conventional clinical indicated diagnostic procedures (lung function test, chest-X-ray, CT)
Exclusion Criteria
* 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.
1 Day
6 Years
ALL
Yes
Sponsors
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Mukoviszidose Institut gGmbH
OTHER
Heidelberg University
OTHER
German Cancer Research Center
OTHER
Responsible Party
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Helmholz society
Principal Investigators
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Michael Puderbach, MD
Role: PRINCIPAL_INVESTIGATOR
German Cancer Research Center
Locations
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German Cancer Research Center
Heidelberg, , Germany
Countries
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References
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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.
Related Links
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German Cystic Fibrosis Foundation
Other Identifiers
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387/2005
Identifier Type: -
Identifier Source: org_study_id
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