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NCT02100358 Clinical Trial

Functional MRC With Eovist for Acute Cholecystitis

Acute Cholecystitis Clinical Trial

— MRC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02100358
Other study ID # 403462
Secondary ID
Status Completed
Phase N/A
First received March 20, 2014
Last updated May 24, 2017
Start date February 2013
Est. completion date April 2016

Study information
Verified date May 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of positive cases of acute cholecystitis The primary outcome measure is the number of positive cases of acute cholecystitis on functional magnetic resonance imaging 2 years
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