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

Esaote

Status: Completed

Conditions: Abdominal Pain

Treatments: Diagnostic Test: Diagnostic MRI

Study type: Observational

Funder types: Industry

Identifiers

NCT06049563

CIP000001

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

40 participants in 1 patient group

Enrolled subjects

Description:

An additional MRI scan of the upper abdomen will be performed on all the subjects with the low-field 0.4 T MRI system.

Treatment:

Diagnostic Test: Diagnostic MRI