Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT01121094
Status:
UNKNOWN
Last Update Posted:
2010-05-12
First Post:
2010-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-05-11', 'studyFirstSubmitDate': '2010-05-09', 'studyFirstSubmitQcDate': '2010-05-11', 'lastUpdatePostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver, spleen , T2* , MRI, fetus'], 'conditions': ['Iron Overload']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prospectively evaluated the T2\\* values of normal feti.A standardized scale of T2\\* values for fetal and neonatal iron organ overload have yet to be reported or devised.', 'detailedDescription': 'The purpose of this study is to prospectively evaluate the T2\\* values of normal feti. This study will be offered to mothers undergoing fetal MRI for any indication. Subjects will be required to sign an informed consent from. The addition of T2\\* sequences will add 2-4 minutes to the whole scan, not exposing the mother or the fetus to ionizing radiation or the administration of contrast material. A standardized scale has been created and multi-center studies have been conducted using different vendor scanners in order to verify the consistency of these scale. T2 and T2\\* sequences have been addressed anecdotally in the literature as non invasive options for the evaluation fetal iron deposition . However, a standardized scale of T2\\* values for fetal and neonatal iron organ overload have yet to be reported or devised.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be offered to motheres undergoing fetal MRI for any indication.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any MRI study for fetus\n\nExclusion Criteria:\n\n* Known iron deposition problem in the mother of fetus'}, 'identificationModule': {'nctId': 'NCT01121094', 'briefTitle': 'Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences.', 'orgStudyIdInfo': {'id': 'SHEBA-09-7502-OG-SMC'}}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'Orly Goitein, MD', 'role': 'CONTACT', 'phone': '+972 3 5302530'}, {'name': 'Orly Goitein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba medical center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Orly Goitein, MD', 'role': 'CONTACT', 'email': 'orly.goitein@sheba.health.gov.il', 'phone': '+972 3 5302530'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Sheba Medical Center', 'oldOrganization': 'Sheba Medical Center'}}}}