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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic MRI | Diagnostic Test | MRI scan of the upper abdomen performed with the low-field 0.4T MRI system. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Name | Affiliation | Role |
|---|---|---|
| Pierpaolo Palumbo, MD | U.O.C Radiologia II Universitaria, S. Salvatore Hospital, L'Aquila, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O.C Radiologia II Universitaria, S. Salvatore Hospital, | L’Aquila | 67100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9465952 | Background | Wacker F, Branding G, Zimmer T, Faiss S, Wolf KJ. [MR cholangiopancreatography using an open low field system of 0.2 tesla: early clinical results compared with a high field system (1.5 tesla) and ERCP]. Rofo. 1997 Dec;167(6):579-84. doi: 10.1055/s-2007-1015586. German. |
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There's no plan to make individual partecipant data (IPD) available to other researches
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| D012817 | Signs and Symptoms, Digestive |