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Completed

NCT Number: NCT00760071

Magnetic Resonance Imaging (MRI) for Early Diagnosis of 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.

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Key information

Age range

1 day–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

German Cancer Research Center

Heidelberg, 69120, Germany

About this study

Month 1-2: Protocol adaptation for infants and small children Month 3-14: Patient examinations (20 Patients with sedation) Month 15-18: Data evaluation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Collaborators

  • Heidelberg University
  • Mukoviszidose Institut gGmbH

Registry information

Official study title

Evaluation of Morphological and Functional Magnetic Resonance Imaging (MRI) for Early Diagnosis of Lung Changes in Children (0-6 Years) With Cystic Fibrosis (CF)

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Apr 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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