Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 8:49 AM
Study NCT ID:
NCT00587535
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006432', 'term': 'Hemochromatosis'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D008664', 'term': 'Metal Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D019190', 'term': 'Iron Overload'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of MR in quantifying liver iron', 'timeFrame': 'one time point'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hemochromatosis', 'liver cirrhosis', 'liver diseases'], 'conditions': ['Hemochromatosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a new MR pulse sequence is accurate in determining how much iron is in the liver.', 'detailedDescription': 'Quantification of liver iron requires liver biopsy and histological assessment. New rapid MR techniques allow determination of liver relaxation times that can be altered with increasing iron deposition. The purpose of this study is to compare the results obtained with MRI to liver biopsy and iron quantification in patients undergoing liver biopsy in the setting of hemochromatosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Gastroenterology Clinic; Liver Transplant Center; Surgery Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing liver biopsy for suspected or known hemochromatosis\n* Undergoing liver biopsy for living-related liver donation evaluation\n\nExclusion Criteria:\n\n* Contraindication to MRI'}, 'identificationModule': {'nctId': 'NCT00587535', 'briefTitle': 'Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration', 'orgStudyIdInfo': {'id': '1478-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemochromatosis', 'description': 'Hemochromatosis'}, {'label': 'Living-related liver donation', 'description': 'Living-related liver donation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Jeff L Fidler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology College of Medicine', 'investigatorFullName': 'Jeff Fidler', 'investigatorAffiliation': 'Mayo Clinic'}}}}