Trial Information
Evaluation of Morphological and Functional Magnetic Resonance Imaging (MRI) for Early Diagnosis of Lung Changes in Children (0-6 Years) With Cystic Fibrosis (CF)
Month 1-2: Protocol adaptation for infants and small children Month 3-14: Patient
examinations (20 Patients with sedation) Month 15-18: Data evaluation
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Crossover, Time Perspective: Prospective
Principal Investigator
Michael Puderbach, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
German Cancer Research Center
Authority:
Germany: Ethics Commission
Study ID:
387/2005
NCT ID:
NCT00760071
Start Date:
July 2006
Completion Date:
September 2009
Related Keywords:
- Cystic Fibrosis
- Lung Disease
- cystic fibrosis,
- lung disease,
- MRI,
- morphology,
- function
- morphological MRI
- functional MRI
- correlation to clinical data
- Cystic Fibrosis
- Fibrosis
- Lung Diseases