Evaluation of Upper Abdomen Imaging With Low Field MRI Scanner (0.4T)

Study Overview
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Brief Summary
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The goal of this observational, cross-sectional, prospective study is to compare the quality of the image obtained on the upper abdomen organs with a low-field 0.4 T MRI system with the one obtained with a high-field 1.5 T MRI system, taken as a comparator and reference device. The study is conducted on 40 consecutive adults, not vulnerable, patients who are already scheduled for diagnostic imaging examinations on the upper abdominal organs with the reference device.

Detailed Description
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The Primary endpoint of the study is to : a) compare the image quality of the upper abdominal organs obtained with 0.4 T systems and with 1.5 T systems; This will be assessed via a noninferiority study on image quality. The image quality will be assessed by two experienced radiologists (more than 5 years' experience) and a trainee radiologist (at least 2 years) via blinded independent readings of the diagnostic images acquired both on the low-field 0.4T MRI device and on reference device e.g. the high-end 1.5T MRI device Secondary endpoints of this study are: evaluate the accuracy of representation and measurement (diameters, volumes) of the gallbladder and bile and pancreatic ducts; compare the exam comfort with 0.4 T systems and with 1.5 T systems by means of questionnaires on the exam comfort provided to the subjects

Official Title
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Evaluation of Imaging Acquisition Protocol for the Upper Abdomen Scan on a Low Field MRI Scanner (0.4T) and Comparison of the Image Quality Obtained With Respect to the Conventional Examination Performed on a High Field MRI Scanner (1.5T)

Conditions
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Abdominal Pain

Intervention / Treatment
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* Diagnostic Test: Diagnostic MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all subjects (in-patients or out-patients) who go to the diagnostic clinical center with the indication of performing an upper abdomen MRI examination with MRI 1.5T age :18 years old or higher the subject must be capable and willing to fulfill all study requirements Exclusion Criteria: pregnancy, poor cooperation claustrophobia (only for 1.5T MRI)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Enrolled subjects<br>An additional MRI scan of the upper abdomen will be performed on all the subjects with the low-field 0.4 T MRI system. | Diagnostic Test: Diagnostic MRI<br>* MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality assessment | Assess the image quality obtained with Low field 0.4 T MRI scan of the upper abdomen with the hig-field 1.5 T MRI scans of the same body part | On average within 7 days from intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurements accuracy: Linear measurements | accuracy of the measurement: diameters of gallbladder, bile and pancreatic ducts in millimeters (mm) | On average within 7 days from the intervention | 
| Measurements accuracy: volumetric measurement | accuracy of the measurement: diameters of gallbladder, bile and pancreatic ducts will be combined to report the related volume in milliliters (cm^3) | On average within 7 days from the intervention | 
| Comfort of the Exam | Data related to the comfort of the exam are collected utilizing a survey provided to the subjects entitled Evaluation of exam comfort. The survey reports scores on a scale. For each question the subject will assign a score ranging from 1 to 5 is assigned where value 1 represents the value corresponding to the highest level of satisfaction and the value 5 to the lowest. | immediately after the intervention |