Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00760071
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : April 15, 2010
Mukoviszidose Institut gGmbH
Heidelberg University
Information provided by:
German Cancer Research Center

Brief Summary:

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.

Condition or disease
Cystic Fibrosis Lung Disease

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

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official 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)
Study Start Date : July 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Patients with diagnoses of cystic fibrosis from birth to the age of 6 years
2 controls
age matched controls

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed CF-patients (male/female), age 0-6 years

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00760071

German Cancer Research Center
Heidelberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
Mukoviszidose Institut gGmbH
Heidelberg University
Principal Investigator: Michael Puderbach, MD German Cancer Research Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: German Cancer Research Center, Helmholz society Identifier: NCT00760071     History of Changes
Other Study ID Numbers: 387/2005
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: April 15, 2010
Last Verified: April 2010

Keywords provided by German Cancer Research Center:
cystic fibrosis,
lung disease,
morphological MRI
functional MRI
correlation to clinical data

Additional relevant MeSH terms:
Cystic Fibrosis
Lung Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases