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Functional MRC With Eovist for Acute Cholecystitis

Sponsor
University of California, Davis (Other)
Overall Status
Completed
CT.gov ID
NCT02100358
Collaborator
(none)
17
Enrollment
1
Location
37.9
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    17 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy
    Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Apr 1, 2016
    Actual Study Completion Date :
    Apr 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    acute cholecystitis

    acute cholecystitis

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Davis Medical Center Sacramento California United States 95817

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT02100358
    Other Study ID Numbers:
    • 403462
    First Posted:
    Mar 31, 2014
    Last Update Posted:
    May 30, 2017
    Last Verified:
    May 1, 2017
    Keywords provided by University of California, Davis
    acute cholecystitis
    Additional relevant MeSH terms:
    Cholecystitis
    Acalculous Cholecystitis
    Cholecystitis, Acute

    Study Results

    No Results Posted as of May 30, 2017