Status:
COMPLETED
MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
The aim of the study is to assess the diagnostic sensitivity of MRI to detect changes in Helbich-Bhalla scoring over time in patients with cystic fibrosis
Detailed Description
Cystic fibrosis (CF) is caused by the cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation and represents one of the most frequent and lethal inherited disease in Caucasian. Howeve...
Eligibility Criteria
Inclusion
- male or female children (age ≥ 8 y.o) and adult patient with a diagnosis of cystic fibrosis provided by genetic and swear test older than 8 years. Subgroups of patients will be defined according to:
- age: younger or older 18y.o. We expect around 50% in different subgroups. In case of, we reach 50% in one of these groups, patient recruitment will continue for both groups until the expected number of patients in the study is reached.
- brand name of magnet: Siemens, General Electric or Philips
- new drugs use: association Ivacaftor/lumicaftor (OrkambiØ) or Ivacaftor only (Kalydeco Ø) ) We expect approximately 20% to 50% of patients treated
- Informed consent provided to the patient or/and to legal representative for adults and to parents for the children
- Patient concerned by articles L 1121-6, L 1121-7, and L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent) if the expected benefit for such persons justifies the foreseeable risk incurred
Exclusion
- patients without any social security or health insurance
- pregnant women
- Patients with previous pulmonary transplantation or planned for transplantation in the year following inclusion
- MRI contraindications:
Key Trial Info
Start Date :
May 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT03357562
Start Date
May 5 2018
End Date
March 6 2025
Last Update
March 20 2025
Active Locations (11)
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1
University Hospital of Bordeaux
Bordeaux, France, 33000
2
University Hospital of Bordeaux
Bordeaux, France, 33076
3
Hôpital Henri Mondor
Créteil, France, 94010
4
CHRU de Grenoble
Grenoble, France, 38043