Acute CholecystitisMRCNCT02100358
Functional MRC With Eovist for Acute Cholecystitis
An observational study of Acute Cholecystitis, run by University of California, Davis at 1 site in United States.
Trial summary
Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an accurate method of diagnosing acute cholecystitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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 -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy
Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an accurate method of diagnosing acute cholecystitis.
Read the 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.
- Conditions
- Acute Cholecystitis
- Keywords
- acute cholecystitis
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute cholecystitis | acute cholecystitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startFeb 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael T Corwin, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100358
- Sponsor's protocol ID
- 403462
- Acronym
- MRC
- Status last verified
- May 2017
- First submitted
- 20 Mar 2014
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy
- ClinicalTrials.gov ID
- NCT02100358
- Acronym / sponsor ID
- MRC / 403462
- Conditions
- Acute Cholecystitis
- Keywords
- acute cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute cholecystitis | – | –acute cholecystitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael T Corwin, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cholecystitis, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of positive cases of acute cholecystitis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.