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)

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain
• Intervention / Treatment: Diagnostic test: Diagnostic MRI

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

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • U.O.C Radiologia II Universitaria, S. Salvatore Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 test: Diagnostic MRI; MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Esaote S.p.A.
• Investigators: Principal Investigator: Pierpaolo Palumbo, MD, U.O.C Radiologia II Universitaria, S. Salvatore Hospital, L'Aquila, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Actual): April 27, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: CIP000001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There's no plan to make individual partecipant data (IPD) available to other researches

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No