E84.0 E84.1 E84.8
Conditions
Interventions
Group 1: - As part of the routine examinations of CF patients, a native MRI of the abdomen is performed with standard sequences compared to two modern sequences (RAVE hybrid sequence and DWI with SMS
Sponsors
Institut für Diagnostische und Interventionelle RadiologieSektion Kinderradiologie
Eligibility
Sex/Gender
All
Age
6 Years to 30 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: Quantitative and qualitative comparison of image quality of standard and modern abdominal MRI sequences in an intraindividual study design. - Determination of diagnostic image quality (5-point Likert scale) - Determination of SNR/CNR - Determination of ADC Acceptance: - Determination of examination time in MRI comparing standard sequences vs. modern sequences. - Determination of examination duration in ultrasound. - Determination of the abdominal MRI discontinuation rate before acquisition of all study sequences. Additional questionnaire on - subjective noise assessment of the MRI examination - subjective sensation during the MRI examination itself - subjective perception of the spatial confinement in the MRI machine - Subjective perception of the duration of the MRI examination | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion and type of imaging findings in CF in abdominal sonography - Proportion and type of imaging findings in CF in MRI of the abdomen - 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) | — |
Countries
Germany
Contacts
Public ContactKatja Glutig
Universitätsklinikum Jena,Institut für Diagnostische und Interventionelle RadiologieSektion Kinderradiologie
Outcome results
None listed