Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 2:23 PM
Study NCT ID:
NCT01050166
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2010-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Imaging of Labeled Human Islets Transplanted Into the Liver
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08-15'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2010-01-14', 'studyFirstSubmitQcDate': '2010-01-14', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['islet transplantation', 'magnetic resonance', 'Type 1 DM'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21197715', 'type': 'RESULT', 'citation': 'Saudek F, Jirak D, Girman P, Herynek V, Dezortova M, Kriz J, Peregrin J, Berkova Z, Zacharovova K, Hajek M. Magnetic resonance imaging of pancreatic islets transplanted into the liver in humans. Transplantation. 2010 Dec 27;90(12):1602-6. doi: 10.1097/tp.0b013e3181ffba5e.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether human islets labeled by iron contrast agents could be imaged using magnetic resonance after transplantation into the liver of Type 1 diabetic recipients.', 'detailedDescription': 'Islet transplantation represents approved therapeutic approach in selected Type 1 diabetic recipients with syndrome of hypoglycaemia unawareness. Existing imaging methods are not sufficient to provide adequate information about amount and fate of islets transplanted into the liver. Labeling of islets with superparamagnetic contrast agent ferucarbotran significantly shortens T2 relaxing time and therefore increase the contrast between islets and liver tissue in magnetic resonance imaging. In consequence, islets transplanted into liver could be easily detectable like hypotensive areas dispersed throughout the liver. MRI examination will be done on 1, 2, 4 weeks and 3, 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cohort will be selected from residents of Czech republic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus\n* normal renal parameters\n* hypoglycaemia unawareness or rapid progression of diabetic retinopathy or neuropathy\n\nExclusion Criteria:\n\n* acute and chronic liver disease\n* malignancy\n* acute infection\n* serious cardiovascular disease\n* coagulopathy\n* portal hypertension\n* presence of metal protesis, cardio-stimulators, or other metal material in the body'}, 'identificationModule': {'nctId': 'NCT01050166', 'briefTitle': 'MRI Imaging of Labeled Human Islets Transplanted Into the Liver', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute for Clinical and Experimental Medicine'}, 'officialTitle': 'Phase 1 Study to Test Safety and Efficacy of Magnetic Resonance Imaging of Human Labeled Islets Transplanted Into the Liver in Type 1 Diabetic Recipients', 'orgStudyIdInfo': {'id': 'CD MRI IKEM 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Labeled islets', 'description': 'Type 1 diabetic recipients after islet transplantation with islets labeled by iron contrast agent', 'interventionNames': ['Other: Transplantation of labeled islets']}], 'interventions': [{'name': 'Transplantation of labeled islets', 'type': 'OTHER', 'armGroupLabels': ['Labeled islets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Diabetes Center, Institute for Clinical and Experimental Medicine', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Frantisek Saudek, MD, DrSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Clinical and Experimental Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frantisek Saudek', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD., prof.', 'investigatorFullName': 'Frantisek Saudek', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}