Clinical trial NCT06049563: Evaluation of Upper Abdomen Imaging With Low Field MRI Scanner (0.4T)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Pain
Lead sponsor: Esaote S.p.A.
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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

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)

Primary outcomes:
measure: Image quality assessment
timeFrame: On average within 7 days from intervention
Secondary outcomes:
measure: Measurements accuracy: Linear measurements
timeFrame: On average within 7 days from the intervention
measure: Measurements accuracy: volumetric measurement
timeFrame: On average within 7 days from the intervention
measure: Comfort of the Exam
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: U.O.C Radiologia II Universitaria, S. Salvatore Hospital,
Study officials:
affiliation: U.O.C Radiologia II Universitaria, S. Salvatore Hospital, L'Aquila, Italy
name: Pierpaolo Palumbo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.