Functional MRC With Eovist for Acute Cholecystitis

NCT ID: NCT02100358

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Cholecystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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acute cholecystitis

acute cholecystitis

No interventions assigned to this group

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael T Corwin, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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UC Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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403462

Identifier Type: -

Identifier Source: org_study_id

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