MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis (NCT03357562) | Clinical Trial Compass
CompletedNot Applicable
MR Imaging of Lung in the Follow-up Assessment of Cystic Fibrosis
France212 participantsStarted 2018-05-05
Plain-language 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
Who can participate
Age range8 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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: