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

NCT ID: NCT06049563

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-21
• Study Completion Date: 2024-08-01

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.

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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 MRI

Intervention Type: DIAGNOSTIC_TEST

MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.

Interventions

Diagnostic MRI

MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esaote S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierpaolo Palumbo, MD

Role: PRINCIPAL_INVESTIGATOR

U.O.C Radiologia II Universitaria, S. Salvatore Hospital, L'Aquila, Italy

Locations

U.O.C Radiologia II Universitaria, S. Salvatore Hospital,

L’Aquila, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 9465952 (View on PubMed)

Other Identifiers

CIP000001

Identifier Type: -

Identifier Source: org_study_id