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

Cystic Fibrosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760071
• Other study ID #: 387/2005
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: April 14, 2010
• Start date: July 2006
• Est. completion date: September 2009

Study information

• Verified date: April 2010
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Disease
• Lung Diseases

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
German Cancer Research Center	Heidelberg University, Mukoviszidose Institut gGmbH

Country where clinical trial is conducted

Germany, 

External Links

•   German Cystic Fibrosis Foundation