Cystic FibrosisNCT00760071
Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)
An observational study of Cystic Fibrosis and Lung Disease, run by German Cancer Research Center at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 1 day to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Lung Disease
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Diagnosed CF-patients (male/female), age 0-6 years
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the 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
- Conditions
- Cystic Fibrosis, Lung Disease
- Keywords
- cystic fibrosis,, lung disease,, MRI,, morphology,, function, morphological MRI, functional MRI, correlation to clinical data
- Medical subject headings
- Cystic Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1CF-patients<6 | Patients with diagnoses of cystic fibrosis from birth to the age of 6 years | |
| 2 controls | age matched controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJul 2006
- Primary completionOct 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mukoviszidose Institut gGmbH, Heidelberg University
- Investigators
- Michael Puderbach, MD, Principal investigator, German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760071
- Sponsor's protocol ID
- 387/2005
- Status last verified
- Apr 2010
- First submitted
- 24 Sep 2008
- Last updated
- 15 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39255452Sommerburg 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.
PubMed 32142375Wielputz 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.
PubMed 24564281
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00760071
- Acronym / sponsor ID
- 387/2005
- Conditions
- Cystic Fibrosis, Lung Disease
- Keywords
- cystic fibrosis,, lung disease,, MRI,, morphology,, function, morphological MRI, functional MRI, correlation to clinical data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Collaborators
- Mukoviszidose Institut gGmbH, Heidelberg University
- Study start
- Jul 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1CF-patients<6 | – | –Patients with diagnoses of cystic fibrosis from birth to the age of 6 years |
| 2 controls | – | –age matched controls |
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Diagnosed CF-patients (male/female), age 0-6 years
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Study exclusion in case of contra indications for MRI:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
- Derived from this study: PubMed 39255452Wielputz 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.
- Derived from this study: PubMed 32142375Sommerburg 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.
- Derived from this study: PubMed 24564281Wielputz 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.
- German Cystic Fibrosis FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Puderbach, MD principal investigator
German Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Lung Disease, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00760071, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2010.