Pilot study on the feasibility and acceptability of abdominal MRI with modern sequences in patients with cystic fibrosis.

Recruiting

Conditions: E84.0
E84.1
E84.8
Cystic fibrosis with pulmonary manifestations
Cystic fibrosis with intestinal manifestations
Cystic fibrosis with other manifestations

Registration Number: DRKS00024529

Lead Sponsor: Institut für Diagnostische und Interventionelle RadiologieSektion Kinderradiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 15

Inclusion Criteria

Diagnosed CF disease
- Age > 6 years
- Pancreatic insufficiency
- Informed consent of the adult patient
- Informed consent of both or the custodial parent in case of children under 18 years of age

Exclusion Criteria

- Applicable exclusion criteria for the performance of an MRI examination and the application of Buscopan.
- Cardiac pacemakers, ferromagnetic foreign bodies, pronounced tattoos.
- Lung or other organ transplants
- Pregnancy
- Claustrophobia
- The examination must be feasible without sedation or anaesthesia, i.e. pronounced restlessness, considerable pain when lying down are a criterion for exclusion.
- Lack of informed consent
- Lack of consent from both parents or the custodial parent in the case of children under 18 years of age.
- Verbal or written withdrawal of the declaration of consent

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility:<br>Quantitative and qualitative comparison of image quality of standard and modern abdominal MRI sequences in an intraindividual study design. <br>- Determination of diagnostic image quality (5-point Likert scale)<br>- Determination of SNR/CNR<br>- Determination of ADC<br><br>Acceptance:<br>- Determination of examination time in MRI comparing standard sequences vs. modern sequences.<br>- Determination of examination duration in ultrasound.<br>- Determination of the abdominal MRI discontinuation rate before acquisition of all study sequences.<br><br>Additional questionnaire on <br>- subjective noise assessment of the MRI examination<br>- subjective sensation during the MRI examination itself<br>- subjective perception of the spatial confinement in the MRI machine<br>- Subjective perception of the duration of the MRI examination

Secondary Outcome Measures

Name	Time	Method
- Proportion and type of imaging findings in CF in abdominal sonography<br>- Proportion and type of imaging findings in CF in MRI of the abdomen<br>- Proportion of CF patients with abdominal complications according to the cut-off of greater than 9.6 according to the CFAbd score (questionnaire for CF patients on abdominal complications)