Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT00585767
Status:
WITHDRAWN
Last Update Posted:
2017-05-30
First Post:
2007-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional, Dynamic, and Anatomic MR Urography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006869', 'term': 'Hydronephrosis'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2001-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hydronephrosis'], 'conditions': ['Hydronephrosis']}, 'descriptionModule': {'briefSummary': 'This is a clinical feasibility study to assess the value of MR imaging for obtaining functional, dynamic and anatomical information in a comprehensive imaging protocol in subjects having obstructive uropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have been diagnosed with obstructive uropathy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females 18 years of age or older.\n* All female patients of childbearing potential must agree to use a medically accepted method of contraception at the time of the study.\n* Patients must have the ability to understand the requirements of the study, provide written and informed consent to participate, and agree to abide by the study requirements.\n* Patients who have known or suspected hydronephrosis or patients with solitary kidneys.\n\nExclusion Criteria:\n\n* Patients with known or suspected hypersensitivity to gadolinium-based agents.\n* Patients who are pregnant or lactating.\n* Patients with a condition that is a contraindication to MRI (e.g., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other conditions that would preclude patient proximity to a strong external magnetic field).\n* Patients with a recent history of hemolytic anemia, sickle cell anemia or other hemoglobinopathy.\n* Patients with a history of significant claustrophobia.\n* Patients with impaired renal function based on 24-hr urine collection (creatinine clearance \\<10 ml/min or serum creatinine \\>1.8 mg/dl)'}, 'identificationModule': {'nctId': 'NCT00585767', 'briefTitle': 'Functional, Dynamic, and Anatomic MR Urography', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Functional, Dynamic, and Anatomic MR Urography', 'orgStudyIdInfo': {'id': '200311391'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients with two kidneys'}, {'label': '2', 'description': 'Patients with solitary kidney'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard Katzburg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}