Brief Title
Functional MRC With Eovist for Acute Cholecystitis
Official Title
Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy
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 Type
Observational
Primary Outcome
Number of positive cases of acute cholecystitis
Condition
Acute Cholecystitis
Study Arms / Comparison Groups
acute cholecystitis
Description: acute cholecystitis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
17
Start Date
February 2013
Completion Date
April 2016
Primary Completion Date
April 2016
Eligibility Criteria
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 -
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michael T Corwin, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02100358
Organization ID
403462
Responsible Party
Sponsor
Study Sponsor
University of California, Davis
Study Sponsor
Michael T Corwin, MD, Principal Investigator, Assistant Professor
Verification Date
May 2017