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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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: 1. evaluate the accuracy of representation and measurement (diameters, volumes) of the gallbladder and bile and pancreatic ducts; 2. 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

Related Conditions & MeSH terms

Abdominal Pain

Clinical Trial Details

NCT number	NCT06049563
Study type	Observational
Source	Esaote S.p.A.
Contact	Pierpaolo Palumbo, MD
Phone	+39-0862-368512
Email	ppalumbo@asl1abruzzo.it
Status	Recruiting
Phase
Start date	December 21, 2023
Completion date	June 2024

View Details

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