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

NCT00760071 | Completed DMC

• 1 other identifier: 387/2005
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Lung Disease

Keywords

cystic fibrosis,; lung disease,; MRI,; morphology,; function; morphological MRI; functional MRI; correlation to clinical data

Study Arms (2)

1CF-patients<6

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

2 controls

age matched controls

Eligibility Criteria

• Age: 1 Day - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed CF-patients (male/female), age 0-6 years

You may qualify if:

• 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)

You may not qualify if:

• 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 & Collaborators

• German Cancer Research Center: lead
• Mukoviszidose Institut gGmbH: collaborator
• Heidelberg University: collaborator

Study Sites (1)

German Cancer Research Center

Heidelberg, 69120, Germany

Location

Related Publications (3)

• Wielputz MO, Stahl M, Triphan SMF, Wucherpfennig L, Leutz-Schmidt P, Gestewitz S, Steinke E, Graeber SY, Kauczor HU, Eichinger M, Puderbach MU, Alrajab A, Schenk JP, Sommerburg O, Mall MA. Longitudinal Magnetic Resonance Imaging of Changes in Lung Morphology and Perfusion in Children with Cystic Fibrosis from Infancy through Adolescence. Ann Am Thorac Soc. 2025 Jan;22(1):93-103. doi: 10.1513/AnnalsATS.202404-396OC.

  PMID: 39255452 DERIVED

• Sommerburg O, Wielputz MO, Trame JP, Wuennemann F, Opdazaite E, Stahl M, Puderbach MU, Kopp-Schneider A, Fritzsching E, Kauczor HU, Baumann I, Mall MA, Eichinger M. Magnetic Resonance Imaging Detects Chronic Rhinosinusitis in Infants and Preschool Children with Cystic Fibrosis. Ann Am Thorac Soc. 2020 Jun;17(6):714-723. doi: 10.1513/AnnalsATS.201910-777OC.

  PMID: 32142375 DERIVED

• Wielputz MO, Puderbach M, Kopp-Schneider A, Stahl M, Fritzsching E, Sommerburg O, Ley S, Sumkauskaite M, Biederer J, Kauczor HU, Eichinger M, Mall MA. Magnetic resonance imaging detects changes in structure and perfusion, and response to therapy in early cystic fibrosis lung disease. Am J Respir Crit Care Med. 2014 Apr 15;189(8):956-65. doi: 10.1164/rccm.201309-1659OC.

  PMID: 24564281 DERIVED

Related Links

• German Cystic Fibrosis Foundation

MeSH Terms

Conditions

Cystic Fibrosis; Lung Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Michael Puderbach, MD

  German Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: July 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: September 1, 2009
• Last Updated: April 15, 2010

Record last verified: 2010-04

Locations

DE (1)