NCT02100358

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

March 20, 2014

Last Update Submit

May 24, 2017

Conditions

Acute Cholecystitis

Keywords

acute cholecystitis

Outcome Measures

Primary Outcomes (1)

  • Number of positive cases of acute cholecystitis

    The primary outcome measure is the number of positive cases of acute cholecystitis on functional magnetic resonance imaging

    2 years

Study Arms (1)

acute cholecystitis

acute cholecystitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Michael T Corwin, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

March 31, 2014

Study Start

February 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

US(1)