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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06049563
Other study ID # CIP000001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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