- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00760071
Magnetic Resonance Imaging (MRI) for Early Diagnosis of Cystic Fibrosis (CF)
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.
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.
연구 개요
상세 설명
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Heidelberg, 독일, 69120
- German Cancer Research Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 크로스오버
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
|---|
|
1CF-patients<6
Patients with diagnoses of cystic fibrosis from birth to the age of 6 years
|
|
2 controls
age matched controls
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Michael Puderbach, MD, German Cancer Research Center
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .