Functional MRC With Eovist for Acute Cholecystitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02100358

Acronym

MRC

Enrollment

Registered

2014-03-31

Start date

2013-02-28

Completion date

2016-04-30

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholecystitis

Keywords

acute cholecystitis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 -

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results