Functional MRC With Eovist for Acute Cholecystitis

Completed

• Conditions: Acute Cholecystitis

• Registration Number: NCT02100358
• Lead Sponsor: University of California, Davis

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of positive cases of acute cholecystitis	2 years	The primary outcome measure is the number of positive cases of acute cholecystitis on functional magnetic resonance imaging

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States