Skip to main content
OpenTrials
Completed

NCT Number: NCT02100358

Functional MRC With Eovist for Acute Cholecystitis

Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an accurate method of diagnosing acute cholecystitis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

About this study

Primary Objective:

To determine the accuracy of fMRC in evaluating patients with suspected cholecystitis.

Secondary Objective:

To compare the results of fMRC with conventional hepatobiliary scintigraphy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Symptoms of right upper quadrant pain with ambiguous US (and/or CT) findings
  • Standard of care nuclear medicine hepatobiliary scan to rule out acute cholecystitis -

Exclusion criteria

  • Scheduled for emergent surgery, or is otherwise determined by the Investigator that the subject is clinically unsuitable for the study
  • Glomerular filtration rate (GFR) below 60 mL/min/1.73m2
  • Total bilirubin above 3.0 mg/dL
  • Inability to provide informed consent (altered or diminished mental status)
  • Allergic to morphine
  • Known or suspected hypersensitivity to gadolinium-based agents
  • The standard MRI contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (IUDs), penile implants, inferior vena cava (IVC) filters, gunshot wounds with retained bullet fragments.
  • Pregnant or breast-feeding -

Treatment and study plan

Primary outcomes

  1. Number of positive cases of acute cholecystitis

    Time frame: 2 years

    The primary outcome measure is the number of positive cases of acute cholecystitis on functional magnetic resonance imaging

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy

Acronym: MRC

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2014
Registry last updated
May 30, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.