Evaluation of Upper Abdomen Imaging With Low Field MRI Scanner (0.4T)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The Primary endpoint of the study is to :
- 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:
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evaluate the accuracy of representation and measurement (diameters, volumes) of the gallbladder and bile and pancreatic ducts;
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Enrolled subjects 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
MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.
|
Outcome Measures
Primary Outcome Measures
- Image quality assessment [On average within 7 days from intervention]
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
Secondary Outcome Measures
- Measurements accuracy: Linear measurements [On average within 7 days from the intervention]
accuracy of the measurement: diameters of gallbladder, bile and pancreatic ducts in millimeters (mm)
- Measurements accuracy: volumetric measurement [On average within 7 days from the intervention]
accuracy of the measurement: diameters of gallbladder, bile and pancreatic ducts will be combined to report the related volume in milliliters (cm^3)
- Comfort of the Exam [immediately after the intervention]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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age :18 years old or higher
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the subject must be capable and willing to fulfill all study requirements
Exclusion Criteria:
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pregnancy,
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poor cooperation
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claustrophobia (only for 1.5T MRI)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Esaote S.p.A.
Investigators
- Principal Investigator: Pierpaolo Palumbo, MD, U.O.C Radiologia II Universitaria, S. Salvatore Hospital, L'Aquila, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
- CIP000001