Functional MRC With Eovist for Acute Cholecystitis

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Cholecystitis
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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