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

Abdominal Pain Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049563
• Other study ID #: CIP000001
• Status: Recruiting
• Start date: December 21, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Esaote S.p.A.
• Contact: Pierpaolo Palumbo, MD
• Phone: +39-0862-368512
• Email: ppalumbo[@]asl1abruzzo.it
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Diagnostic Test:
• Diagnostic MRI
MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.

Locations

Country	Name	City	State
Italy	U.O.C Radiologia II Universitaria, S. Salvatore Hospital,	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
Esaote S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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