Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02100358
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2014-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional MRC With Eovist for Acute Cholecystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-24', 'studyFirstSubmitDate': '2014-03-20', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of positive cases of acute cholecystitis', 'timeFrame': '2 years', 'description': 'The primary outcome measure is the number of positive cases of acute cholecystitis on functional magnetic resonance imaging'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute cholecystitis'], 'conditions': ['Acute Cholecystitis']}, 'descriptionModule': {'briefSummary': 'Functional magnetic resonance cholangiography (fMRC) with gadoxetate disodium (Eovist) is an accurate method of diagnosing acute cholecystitis.', 'detailedDescription': 'Primary Objective:\n\nTo determine the accuracy of fMRC in evaluating patients with suspected cholecystitis.\n\nSecondary Objective:\n\nTo compare the results of fMRC with conventional hepatobiliary scintigraphy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have recently (within 12 hours) undergone a clinically-indicated nuclear medicine hepatobiliary scan not involving sedation or anesthesia for suspected acute cholecystitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Symptoms of right upper quadrant pain with ambiguous US (and/or CT) findings\n* Standard of care nuclear medicine hepatobiliary scan to rule out acute cholecystitis -\n\nExclusion Criteria:\n\n* Scheduled for emergent surgery, or is otherwise determined by the Investigator that the subject is clinically unsuitable for the study\n* Glomerular filtration rate (GFR) below 60 mL/min/1.73m2\n* Total bilirubin above 3.0 mg/dL\n* Inability to provide informed consent (altered or diminished mental status)\n* Allergic to morphine\n* Known or suspected hypersensitivity to gadolinium-based agents\n* 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.\n* Pregnant or breast-feeding -'}, 'identificationModule': {'nctId': 'NCT02100358', 'acronym': 'MRC', 'briefTitle': 'Functional MRC With Eovist for Acute Cholecystitis', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Accuracy of Functional MRC With Gadoxetate Disodium in the Diagnosis of Acute Cholecystitis: Comparison With Hepatobiliary Scintigraphy', 'orgStudyIdInfo': {'id': '403462'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute cholecystitis', 'description': 'acute cholecystitis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Michael T Corwin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}