Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-21 @ 9:44 PM
Study NCT ID:
NCT00575432
Status:
UNKNOWN
Last Update Posted:
2022-11-14
First Post:
2007-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Kidney Function by Multi-modal Magnetic Resonance Imaging and Spectroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014545', 'term': 'Urinary Calculi'}], 'ancestors': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'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'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056324', 'term': 'Diffusion Tensor Imaging'}, {'id': 'D016896', 'term': 'Treatment Outcome'}], 'ancestors': [{'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D038524', 'term': 'Diffusion Magnetic Resonance Imaging'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011379', 'term': 'Prognosis'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2007-12-17', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of functional MR parameters with histology results as "gold standard" or with final clinical outcome', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Correlation with clinical results, laboratory results (e.g. GFR, serum-creatinine levels), results from other imaging procedures, correlation within MR parameters (e.g. in vivo metabolites vs. in vitro (from urine) metabolites, oxygenation vs. diffusion)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['magnetic resonance imaging', 'renal function', 'renal transplant', 'urinary calculi', 'healthy controls', 'kidney'], 'conditions': ['Kidney Transplantation', 'Urinary Calculi']}, 'referencesModule': {'references': [{'pmid': '34447762', 'type': 'BACKGROUND', 'citation': 'Mani LY, Seif M, Nikles F, Tshering Vogel DW, Diserens G, Martirosian P, Burnier M, Vogt B, Vermathen P. Hip Position Acutely Affects Oxygenation and Perfusion of Kidney Grafts as Measured by Functional Magnetic Resonance Imaging Methods-The Bent Knee Study. Front Med (Lausanne). 2021 Aug 10;8:697055. doi: 10.3389/fmed.2021.697055. eCollection 2021.'}, {'pmid': '35743353', 'type': 'BACKGROUND', 'citation': 'Mani LY, Cotting J, Vogt B, Eisenberger U, Vermathen P. Influence of Immunosuppressive Regimen on Diffusivity and Oxygenation of Kidney Transplants-Analysis of Functional MRI Data from the Randomized ZEUS Trial. J Clin Med. 2022 Jun 8;11(12):3284. doi: 10.3390/jcm11123284.'}, {'pmid': '24582541', 'type': 'RESULT', 'citation': 'Giannarini G, Kessler TM, Roth B, Vermathen P, Thoeny HC. Functional multiparametric magnetic resonance imaging of the kidneys using blood oxygen level dependent and diffusion-weighted sequences. J Urol. 2014 Aug;192(2):434-9. doi: 10.1016/j.juro.2014.02.048. Epub 2014 Feb 25.'}, {'pmid': '24475796', 'type': 'RESULT', 'citation': 'Eisenberger U, Binser T, Thoeny HC, Boesch C, Frey FJ, Vermathen P. Living renal allograft transplantation: diffusion-weighted MR imaging in longitudinal follow-up of the donated and the remaining kidney. Radiology. 2014 Mar;270(3):800-8. doi: 10.1148/radiol.13122588. Epub 2013 Nov 13.'}, {'pmid': '20432350', 'type': 'RESULT', 'citation': 'Binser T, Thoeny HC, Eisenberger U, Stemmer A, Boesch C, Vermathen P. Comparison of physiological triggering schemes for diffusion-weighted magnetic resonance imaging in kidneys. J Magn Reson Imaging. 2010 May;31(5):1144-50. doi: 10.1002/jmri.22156.'}, {'pmid': '20013274', 'type': 'RESULT', 'citation': 'Eisenberger U, Thoeny HC, Binser T, Gugger M, Frey FJ, Boesch C, Vermathen P. Evaluation of renal allograft function early after transplantation with diffusion-weighted MR imaging. Eur Radiol. 2010 Jun;20(6):1374-83. doi: 10.1007/s00330-009-1679-9. Epub 2009 Dec 16.'}, {'pmid': '18403623', 'type': 'RESULT', 'citation': 'Thoeny HC, Kessler TM, Simon-Zoula S, De Keyzer F, Mohaupt M, Studer UE, Vermathen P. Renal oxygenation changes during acute unilateral ureteral obstruction: assessment with blood oxygen level-dependent mr imaging--initial experience. Radiology. 2008 Jun;247(3):754-61. doi: 10.1148/radiol.2473070877. Epub 2008 Apr 10.'}, {'pmid': '17114628', 'type': 'RESULT', 'citation': 'Thoeny HC, Zumstein D, Simon-Zoula S, Eisenberger U, De Keyzer F, Hofmann L, Vock P, Boesch C, Frey FJ, Vermathen P. Functional evaluation of transplanted kidneys with diffusion-weighted and BOLD MR imaging: initial experience. Radiology. 2006 Dec;241(3):812-21. doi: 10.1148/radiol.2413060103.'}, {'pmid': '19567650', 'type': 'RESULT', 'citation': 'Thoeny HC, Binser T, Roth B, Kessler TM, Vermathen P. Noninvasive assessment of acute ureteral obstruction with diffusion-weighted MR imaging: a prospective study. Radiology. 2009 Sep;252(3):721-8. doi: 10.1148/radiol.2523082090.'}, {'pmid': '24962556', 'type': 'RESULT', 'citation': 'Seif M, Lu H, Boesch C, Reyes M, Vermathen P. Image registration for triggered and non-triggered DTI of the human kidney: reduced variability of diffusion parameter estimation. J Magn Reson Imaging. 2015 May;41(5):1228-35. doi: 10.1002/jmri.24671. Epub 2014 Jun 25.'}, {'pmid': '26744926', 'type': 'RESULT', 'citation': 'Seif M, Eisenberger U, Binser T, Thoeny HC, Krauer F, Rusch A, Boesch C, Vogt B, Vermathen P. Renal Blood Oxygenation Level-dependent Imaging in Longitudinal Follow-up of Donated and Remaining Kidneys. Radiology. 2016 Jun;279(3):795-804. doi: 10.1148/radiol.2015150370. Epub 2016 Jan 8.'}, {'pmid': '26871263', 'type': 'RESULT', 'citation': 'Seif M, Mani LY, Lu H, Boesch C, Reyes M, Vogt B, Vermathen P. Diffusion tensor imaging of the human kidney: Does image registration permit scanning without respiratory triggering? J Magn Reson Imaging. 2016 Aug;44(2):327-34. doi: 10.1002/jmri.25176. Epub 2016 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'Multimodal functional magnetic resonance (MR) methods, including MR diffusion, Blood-Oxygenation Level Dependent (BOLD) imaging and MR spectroscopy may provide complementary information about the functional status of a kidney. The researchers hypothesize that these non-invasive methods correlate with histology as "gold standard" and compete favorably with conventional in part invasive evaluation methods, and thus provide specific and early detection of kidney diseases of various etiologies, drug toxicity, or renal allograft dysfunction.', 'detailedDescription': 'Early and specific detection of dysfunction in kidney diseases and differential diagnosis of potential complications in the renal allograft are fundamental to initiate appropriate treatment. In addition, determination of renal function may reveal physiological mechanisms that may prove useful for future therapeutic procedures. Currently, used methods to access renal function like ultrasound, radionuclide imaging, and laboratory methods have several disadvantages, as they are nonspecific, require radioactive contrast agents or are limited in spatial information. Therefore, alternative non-invasive methods to detect early morphological and functional changes are required. Recently, a variety of very promising advanced magnetic resonance imaging (MRI) methods have evolved to obtain functional information of different organs. These methods include MR angiography, diffusion, perfusion and Blood-Oxygenation Level Dependent (BOLD) imaging. In addition to MRI, MR spectroscopy (MRS) provides renal functional information. In abdominal organs like the kidney, respiratory, and cardiac motion and susceptibility artifacts have limited the use of these functional MR methods for clinical applications. However, this may be overcome with the advent of greatly enhanced hardware, allowing very fast imaging times. Besides these in vivo techniques, novel processing algorithms for complex ex vivo MR spectra of body fluids have emerged recently. These methods, labeled "Metabonomics", access renal function by obtaining metabolic profiles that are indicative for renal dysfunction.\n\nThe researchers hypothesize that these non-invasive methods correlate with histology as "gold standard" and compete favorably with conventional in part invasive evaluation methods, and thus provide specific and early detection of kidney diseases of various etiologies, drug toxicity or renal allograft dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Kidney diseases and Renal Allografts', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Minimum age 16 years\n* Male or female\n* Signed consensus report to the study\n\nExclusion Criteria:\n\n* History of allergy to contrast media\n* Pregnancy\n* Contraindication for MR examination: Content of electronic devices in the body of the subject (i.e. pacemaker of heart, implanted insulin pump, nerve stimulator, or similar medical devices), content of metallic foreign bodies or metal-pieces (without amalgam filling), claustrophobia\n* Back or other problems that don't allow motionless lying for 75 minutes\n* Missing signed consensus report to the study"}, 'identificationModule': {'nctId': 'NCT00575432', 'briefTitle': 'Evaluation of Kidney Function by Multi-modal Magnetic Resonance Imaging and Spectroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Evaluation of Kidney Function by Multi-modal Magnetic Resonance Imaging and Spectroscopy in Renal Transplantation and Kidney Disease', 'orgStudyIdInfo': {'id': 'KEK 213/04'}, 'secondaryIdInfos': [{'id': '1066'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Radiation: diffusion MRI', 'Radiation: BOLD MRI', 'Other: Clinical Outcome']}], 'interventions': [{'name': 'diffusion MRI', 'type': 'RADIATION', 'description': 'diffusion MRI', 'armGroupLabels': ['1']}, {'name': 'BOLD MRI', 'type': 'RADIATION', 'description': 'BOLD MRI', 'armGroupLabels': ['1']}, {'name': 'Clinical Outcome', 'type': 'OTHER', 'description': 'Clinical outcome', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Department of Diagnostic and Interventional Neuroradiology', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Harriet C Thoeny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Radiology, University of Bern'}, {'name': 'Peter Vermathen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Bern, Dept.Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}