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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00760071
First Posted: September 25, 2008
Last Update Posted: April 15, 2010
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.
Collaborators:
Mukoviszidose Institut gGmbH
Heidelberg University
Information provided by:
German Cancer Research Center
  Purpose

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
Cystic Fibrosis Lung Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by German Cancer Research Center:

Estimated Enrollment: 30
Study Start Date: July 2006
Study Completion Date: September 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1CF-patients<6
Patients with diagnoses of cystic fibrosis from birth to the age of 6 years
2 controls
age matched controls

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
  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00760071


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Cancer Research Center, Helmholz society
ClinicalTrials.gov Identifier: NCT00760071     History of Changes
Other Study ID Numbers: 387/2005
First Submitted: September 24, 2008
First Posted: September 25, 2008
Last Update Posted: April 15, 2010
Last Verified: April 2010

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

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