Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT01341132
Status:
UNKNOWN
Last Update Posted:
2011-04-25
First Post:
2011-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'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'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C073590', 'term': 'gadolinium ethoxybenzyl DTPA'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-21', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-04-21', 'lastUpdatePostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCC', 'Hepatocellular Carcinoma', 'MRI', 'Liver'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '75 patients of the San Francisco VA Medical Center with suspected HCC identified on contrast-enhanced multi-detector CT, or on ultrasound and referred to contrast-enhanced multi-detector CT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alpha-feto protein \\> 400 ng / mL or\n* prior ultrasound with mass suspicious for hepatic malignancy or.\n* clinical risk of hepatocellular carcinoma or\n* prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma\n\nExclusion Criteria:\n\n* Glomerulo-filtration rate \\< 50 mL/ min/1.73 m2 based on a creatinine measurement within three months of the MR study\n* Previous diagnosis of hepatic malignancy\n* Any conditions that would discount the ability to have an MRI scan'}, 'identificationModule': {'nctId': 'NCT01341132', 'briefTitle': 'Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents', 'organization': {'class': 'FED', 'fullName': 'San Francisco Veterans Affairs Medical Center'}, 'officialTitle': 'Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents', 'orgStudyIdInfo': {'id': '10-03278'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected Liver Disease', 'description': '1. Alpha-feto protein \\> 400 ng / mL or\n2. prior ultrasound with mass suspicious for hepatic malignancy or.\n3. clinical risk of hepatocellular carcinoma or\n4. prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma', 'interventionNames': ['Procedure: MRI Scan of the Liver enhanced with Eovist']}], 'interventions': [{'name': 'MRI Scan of the Liver enhanced with Eovist', 'type': 'PROCEDURE', 'description': '10mL of gadoxetate disodium administered intravenously while being scanned via the MRI. Images will be attained on a 5, 10 and 20 minute delay. Expected scan time is 45 minutes total', 'armGroupLabels': ['Suspected Liver Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Rizwan Aslam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Francisco VA Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Francisco Veterans Affairs Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma', 'class': 'INDUSTRY'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Rizwan Aslam', 'oldOrganization': 'San Francisco Veterans Administration Medical Center'}}}}