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

NCT06049563 | Completed FDA Device

• 1 other identifier: CIP000001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Measurements accuracy: Linear measurements

  On average within 7 days from the intervention

• Measurements accuracy: volumetric measurement

  On average within 7 days from the intervention

• Comfort of the Exam

  immediately after the intervention

Study Arms (1)

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

Interventions

Diagnostic MRI DIAGNOSTIC_TEST

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

Enrolled subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• pregnancy,
• poor cooperation
• claustrophobia (only for 1.5T MRI)

Sponsors & Collaborators

• Esaote S.p.A.: lead

Study Sites (1)

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

L’Aquila, 67100, Italy

Location

Related 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.

  PMID: 9465952 BACKGROUND

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierpaolo Palumbo, MD

  U.O.C Radiologia II Universitaria, S. Salvatore Hospital, L'Aquila, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 22, 2023
• Study Start: December 21, 2023
• Primary Completion: April 27, 2024
• Study Completion: August 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)