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Trial record 33 of 44 for:    Gadoxetate

Functional MRC With Eovist for Acute Cholecystitis (MRC)

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ClinicalTrials.gov Identifier: NCT02100358
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease
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.


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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 : February 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Group/Cohort
acute cholecystitis
acute cholecystitis



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100358


Locations
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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Michael T Corwin, MD Assistant Professor

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02100358     History of Changes
Other Study ID Numbers: 403462
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by University of California, Davis:
acute cholecystitis
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases