Magnetic Resonance Imaging (MRI) for Early Diagnosis of C... | NCT00760071

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

NCT00760071

Sponsor

German Cancer Research Center

Status

Completed

Last Update Posted

Apr 15, 2010Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Cystic Fibrosis
Lung Disease

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Sep 2009Actual

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2010

Last Update Posted Date

Apr 15, 2010Estimated

Name	Class
Mukoviszidose Institut gGmbH	OTHER
Heidelberg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1CF-patients<6		Patients with diagnoses of cystic fibrosis from birth to the age of 6 years
2 controls		age matched controls

Interventions

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

6 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Puderbach, MD	German Cancer Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
German Cancer Research Center		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39255452	Derived	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.
32142375

ID	Term
D003550	Cystic Fibrosis
D008171	Lung Diseases

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn