NCT06049563

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Esaote S.p.A. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Abdominal Pain

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic MRI	MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.

Timeline

• Start date: 2023-12-21
• Primary completion: 2024-04-27
• Completion: 2024-08-01
• First posted: 2023-09-22
• Last updated: 2024-08-29

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study