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Completed

NCT Number: NCT06049563

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

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.

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Key information

Conditions

Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

L’Aquila, 67100, Italy

About this study

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:

  • evaluate the accuracy of representation and measurement (diameters, volumes) of the gallbladder and bile and pancreatic ducts;
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diagnostic MRI

Diagnostic Test

MRI scan of the upper abdomen performed with the low-field 0.4T MRI system.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Esaote S.p.A.

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 22, 2023
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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