Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-01 @ 2:58 PM
Study NCT ID:
NCT01007357
Status:
TERMINATED
Last Update Posted:
2023-07-14
First Post:
2009-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-31', 'releaseDate': '2023-07-15'}, {'resetDate': '2023-12-20', 'releaseDate': '2023-11-29'}, {'resetDate': '2024-01-16', 'releaseDate': '2023-12-20'}], 'estimatedResultsFirstSubmitDate': '2023-07-15'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'whyStopped': 'Principal Investigator left institution; did not complete the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2009-10-28', 'studyFirstSubmitQcDate': '2009-11-03', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimizing body MR imaging sequences', 'timeFrame': '2 years', 'description': 'Healthy volunteers will be used to obtain optimized body MR imaging sequences that will then be used to evaluate MR imaging sequences of subjects with underlying disorders.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diffuse and Focal Abnormalities of the Liver and Pancreas']}, 'descriptionModule': {'briefSummary': 'This project will facilitate the optimization of body MR imaging at 3 Tesla.', 'detailedDescription': 'This project is meant to improve the image quality of multiple sequences at 3.0T applied to the abdominal and pelvic regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between ages of 19 and 65\n* Healthy volunteer subjects should not have any history of disease or symptoms - based on clinical history\n* Subjects with an underlying disorder (diffuse and focal abnormalities of the liver and pancreas)\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* A medical or contraindications that will prevent subjects from having a MRI\n* Subjects with severe renal dysfunction or patients on dialysis'}, 'identificationModule': {'nctId': 'NCT01007357', 'briefTitle': 'Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation', 'orgStudyIdInfo': {'id': '0290-09-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Body MRI healthy volunteers', 'description': 'Body MRI to optimize sequences in healthy individuals and in disorder subjects', 'interventionNames': ['Device: Body MR imaging']}], 'interventions': [{'name': 'Body MR imaging', 'type': 'DEVICE', 'otherNames': ['Body MR imaging performed to optimize sequences'], 'description': 'Body MR imaging will be performed to optimize sequences', 'armGroupLabels': ['Body MRI healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198-1045', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Shahid Hussain, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Medical Systems', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-07-15', 'type': 'RELEASE'}, {'date': '2023-07-31', 'type': 'RESET'}, {'date': '2023-11-29', 'type': 'RELEASE'}, {'date': '2023-12-20', 'type': 'RESET'}, {'date': '2023-12-20', 'type': 'RELEASE'}, {'date': '2024-01-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Nebraska'}}}}