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Sponsored by: |
University Hospital Inselspital, Berne |
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Information provided by: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00575432 |
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.
Condition | Intervention |
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Kidney Transplantation Urinary Calculi |
Radiation: diffusion MRI Radiation: BOLD MRI Radiation: MR spectroscopy |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Factorial Assignment |
Official Title: | Evaluation of Kidney Function by Multi-Modal Magnetic Resonance Imaging and Spectroscopy in Renal Transplantation and Kidney Disease |
Estimated Enrollment: | 200 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
diffusion MRI
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Radiation: diffusion MRI
diffusion MRI
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2
BOLD MRI
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Radiation: BOLD MRI
BOLD MRI
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3
MR spectroscopy
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Radiation: MR spectroscopy
MR spectroscopy
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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. 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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Harriet C Thoeny, MD | 0041 31 632 29 39 | harriet.thoeny@insel.ch |
Contact: Thomas M Kessler, MD | 0041 31 632 20 45 | tkessler@gmx.ch |
Switzerland | |
Department of Urology | Recruiting |
Bern, Switzerland, 3010 | |
Contact: Beat Roth, MD 0041 31 632 20 45 beat.roth@insel.ch | |
Principal Investigator: Harriet C Thoeny, MD | |
Principal Investigator: Thomas M Kessler, MD | |
Principal Investigator: Peter Vermathen, PhD |
Principal Investigator: | Harriet C Thoeny, MD | Institute of Radiology, University of Bern |
Principal Investigator: | Peter Vermathen, PhD | University Bern, Dept.Clinical Research |
Responsible Party: | Institute of Radiology, University of Bern ( Harriet Thoeny, MD, Associate Professor ) |
Study ID Numbers: | KEK 213/04, 1066 |
Study First Received: | December 17, 2007 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00575432 History of Changes |
Health Authority: | Switzerland: Ethikkommission |
magnetic resonance imaging renal function renal transplant |
urinary calculi healthy controls kidney |
Pathological Conditions, Anatomical Urinary Calculi Urologic Diseases Urolithiasis |
Healthy Kidney Diseases Calculi |
Pathological Conditions, Anatomical Urinary Calculi Urologic Diseases Urolithiasis Calculi |