Functional MRC With Eovist for Acute Cholecystitis | NCT02100358

Studies
Functional MRC With Eovist for Acute Cholecystitis

NCT02100358

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

17Actual

Phase

Not provided

Conditions

Acute Cholecystitis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Mar 20, 2014

First Submission Date that Met QC Criteria

Mar 26, 2014

First Posted Date

Mar 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2017

Last Update Posted Date

May 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Label	Type	Description	Intervention Names
acute cholecystitis		acute cholecystitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Michael T Corwin, MD	Assistant Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center		Sacramento	California	95817	United States

Condition Browse Module

MeSH Terms

ID	Term
D041881	Cholecystitis, Acute

Ancestor Terms

ID	Term
D002764	Cholecystitis
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided