Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-31 @ 5:49 PM
Study NCT ID:
NCT01390194
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2011-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2011-07-06', 'studyFirstSubmitQcDate': '2011-07-07', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'image quality outcome', 'timeFrame': '2 years', 'description': 'Two MRI exams will be evaluated by two radiologists based on a number of items.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver disease', 'hepatocellular carcinoma'], 'conditions': ['Underlying Liver Disease', 'Hepatitis', 'Fibrosis of Liver', 'Cirrhosis With Suspicion of Liver Cancer', 'Lesion on a Prior Ultrasound, CT or Outside MRI']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI.', 'detailedDescription': 'This is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (MRI) protocol to standard MRI in participants with suspected hepatocellular carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with an underlying liver disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. underlying liver disease\n2. have a lesion on a prior imaging study\n3. must have prior standard MR\n\nExclusion Criteria:\n\n1. Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;\n2. patients with severe kidney dysfunction'}, 'identificationModule': {'nctId': 'NCT01390194', 'briefTitle': 'Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma: A Pilot Study to Assess the Image Quality (Multitransmit Body MRI Program)', 'orgStudyIdInfo': {'id': '0246-10-FB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subjects with an underlying liver disease', 'description': '(1)underlying liver disease; (2) have a lesion on a prior imaging study; (3) must be prior standard MR'}]}, 'contactsLocationsModule': {'locations': [{'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'}, {'name': 'Bracco Diagnostics, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}