Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-26 @ 5:45 AM
Study NCT ID:
NCT01655550
Status:
UNKNOWN
Last Update Posted:
2012-08-02
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-07-03', 'releaseDate': '2014-06-04'}], 'estimatedResultsFirstSubmitDate': '2014-06-04'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiologist Confidence', 'timeFrame': 'one-time measurement after scan completion', 'description': 'Confidence graded by the radiologist on a scale of 1 to 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Routine Outpatients Undergoing Contrast Enhanced CT Scan of the Abdomen and Pelvis']}, 'descriptionModule': {'briefSummary': 'The investigators seek to demonstrate the non-superiority of oral contrast versus no oral contrast in intravenously enhanced CT in the outpatient setting. The investigators want to decrease preparation time for the patient and decrease delay in obtaining the study which will ultimately lead to faster results and an increased level of patient convenience.\n\nThe investigators hypothesis: Oral contrast does not significantly affect the diagnostic confidence of interpreting radiologists in intravenously enhanced abdominal CT scans.', 'detailedDescription': 'This study will be a randomized controlled trial comparing radiologist confidence when faced with an intravenously enhanced study with and without oral contrast. At the time of making the appointment, the clerk will ask the patient if he/she wishes to participate in a research study about the impact of oral contrast. If the patient assents, he/she will receive a phone call from a research assistant to obtain informed consent. The first ten patients to call the office to schedule a scan using a 64 slice MDCT will be recruited and randomized if they consent.\n\nSubjects will be randomized at the time of recruitment, which will be when he/she calls to make the appointment for the exam, in a 1:1 ratio between the control arm (contrast) and the experimental arm (no contrast). The control arm will either pick up their two bottles of oral contrast at a radiology office or have the bottles mailed to them as is currently the standard. They will drink the oral contrast two hours before the study. They will also ingest 300 mL of water immediately prior to imaging and be administered the standard intravenous contrast dose. The experimental group will not be mailed or given any oral contrast. They will arrive at their appointment and ingest 300 mL of water immediately prior to the exam as well as the standard intravenous contrast dose and be scanned. This design will eliminate the need to repeat scanning patients, thus decreasing radiation dose. A patient satisfaction survey will be given to each patient following the exam and handed to the technologist'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* order for "Contrast Enhanced abdomen CT" or "Contrast Enhanced abdomen/pelvis CT"\n\n * age ≥21\n * able and willing to give consent\n\nExclusion Criteria:\n\n* • allergy to IV contrast\n\n * order for non-contrast CT\n * \\<21\n * pregnant woman\n * order for enterography or colonography\n * history of Crohn\'s Disease or Ulcerative Colitis'}, 'identificationModule': {'nctId': 'NCT01655550', 'briefTitle': 'The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'The Impact of Oral Contrast in Multidetector CT of the Abdomen and Pelvis on Radiologist Confidence: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GARC003501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard of Care', 'description': 'Patients will get routine CT scans with Oral and Intravenous contrast prior to their CT scan as is routine, standard practice', 'interventionNames': ['Other: Withhold oral contrast']}, {'type': 'EXPERIMENTAL', 'label': 'Withold Oral Contrast', 'description': 'Subjects will not drink oral contrast, but instead water (in itself a type of contrast agent) prior to their CT. Intravenous contrast will be administered as is routine', 'interventionNames': ['Other: Withhold oral contrast']}], 'interventions': [{'name': 'Withhold oral contrast', 'type': 'OTHER', 'description': 'The intervention is to withhold oral contrast', 'armGroupLabels': ['Standard of Care', 'Withold Oral Contrast']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bret Coughlin, MD', 'role': 'CONTACT', 'email': 'bcoughlin@jeffersonradiology.com', 'phone': '860-545-5240'}, {'name': 'Bret Coughlin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher M Garcia, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Doug Moote, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': "Michael O'Loughlin, MD", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Davika Jajoo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Steve Lee, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Steve Boe, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jefferson Radiology', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'centralContacts': [{'name': 'Chris Garcia, MD MHS', 'role': 'CONTACT', 'email': 'cgarcia06@harthosp.org', 'phone': '860 545 5240'}], 'overallOfficials': [{'name': 'Christopher M Garcia, MD MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-06-04', 'type': 'RELEASE'}, {'date': '2014-07-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hartford Hospital'}}}}