Functional MRC With Eovist for Acute Cholecystitis (MRC)

May 24, 2017 updated by: University of California, Davis

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

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have recently (within 12 hours) undergone a clinically-indicated nuclear medicine hepatobiliary scan not involving sedation or anesthesia for suspected acute cholecystitis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
acute cholecystitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of positive cases of acute cholecystitis
Time Frame: 2 years
The primary outcome measure is the number of positive cases of acute cholecystitis on functional magnetic resonance imaging
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Michael T Corwin, MD, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 20, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 403462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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