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

• ClinicalTrials.gov Identifier: NCT06049563
• Recruitment Status: Recruiting
• First Posted: September 22, 2023
• Last Update Posted: February 23, 2024
• Sponsor: Esaote S.p.A.
• Information provided by (Responsible Party): Esaote S.p.A.

Study Description

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.

Condition or disease	Intervention/treatment
Abdominal Pain	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 Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: December 21, 2023
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: June 2024

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Image quality assessment [ Time Frame: On average within 7 days from intervention ]
   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

Secondary Outcome Measures :

1. Measurements accuracy: Linear measurements [ Time Frame: On average within 7 days from the intervention ]
   accuracy of the measurement: diameters of gallbladder, bile and pancreatic ducts in millimeters (mm)
2. Measurements accuracy: volumetric measurement [ Time Frame: On average within 7 days from the intervention ]
   accuracy of the measurement: diameters of gallbladder, bile and pancreatic ducts will be combined to report the related volume in milliliters (cm^3)
3. Comfort of the Exam [ Time Frame: immediately after the intervention ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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)

Contacts and Locations

Contacts

Contact: Pierpaolo Palumbo, MD; +39-0862-368512; ppalumbo@asl1abruzzo.it

Contact: Federico Bruno, MD; +39-0862-368500; fbruno@asl1abruzzo.it

Locations

Italy

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

L'Aquila, Italy, 67100

Contact: Pierpaolo Palumbo, MD +39 - 0862368 ext 512 pipalumbo@asl1abruzzo.it

Contact: Federico Bruno, MD +39 - 0862368 ext 500 fbruno@asl1abruzzo.it

Sponsors and Collaborators

Esaote S.p.A.

Investigators

• Principal Investigator: Pierpaolo Palumbo, MD; U.O.C Radiologia II Universitaria, S. Salvatore Hospital, L'Aquila, Italy

More Information

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.

• Responsible Party: Esaote S.p.A.
• ClinicalTrials.gov Identifier: NCT06049563
• Other Study ID Numbers: CIP000001
• First Posted: September 22, 2023
• Last Update Posted: February 23, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive