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

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Abdominal Pain

Clinical Trial Details

NCT number	NCT06049563
Study type	Observational
Source	Esaote S.p.A.
Contact	Pierpaolo Palumbo, MD
Phone	+39-0862-368512
Email	ppalumbo@asl1abruzzo.it
Status	Recruiting
Phase
Start date	December 21, 2023
Completion date	June 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04682860` - Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide	Phase 4
Not yet recruiting	`NCT05649891` - Checklists Resuscitation Emergency Department	N/A
Completed	`NCT02547857` - Transvaginal Pelvic Ultrasound in the ED	N/A
Completed	`NCT02923245` - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound	N/A
Completed	`NCT03318614` - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster	Phase 2/Phase 3
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Completed	`NCT02676232` - DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.	N/A
Recruiting	`NCT00209807` - Effect of Escitalopram vs. Reboxetine on Gastro-intestinal Sensitivity of Patients With Major Depressive Disorder	Phase 4
Terminated	`NCT01410071` - Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction	N/A
Terminated	`NCT01736280` - Evaluating and Treating Potential Research Participants With Digestive Disorders	N/A
Enrolling by invitation	`NCT04104867` - Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy	N/A
Completed	`NCT03574727` - Abdominal Cutaneous Nerve Entrapment Syndrome
Completed	`NCT04614649` - Right Iliac Fossa Treatment-Turkey Audit
Completed	`NCT05438654` - Improvement of Diagnostic Approach Using PoCUS for Right Upper Quadrant Abdominal Pain	N/A
Completed	`NCT06423586` - Effect of Lecithin-based Curcuma and Boswellia on Post-acute COVID-19 IBS	N/A
Completed	`NCT03558009` - Epidemiological Analysis for Hereditary Angioedema Disease
Terminated	`NCT03148288` - Vitamin D Supplementation in IBS	N/A
Completed	`NCT03708874` - Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis
Withdrawn	`NCT04408872` - EUS vs EGD in Emergency Room Patients Referred for EGD	N/A
Recruiting	`NCT02594774` - Efficacy of Osteopathic Treatment in Function Abdominal Pain in Children and Adolescents	N/A