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Evaluation of Kidney Function by Multi-Modal Magnetic Resonance Imaging and Spectroscopy
This study is currently recruiting participants.
Verified by University Hospital Inselspital, Berne, March 2009
First Received: December 17, 2007   Last Updated: March 23, 2009   History of Changes
Sponsored by: University Hospital Inselspital, Berne
Information provided by: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00575432
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Correlation of functional MR parameters with histology results as "gold standard" or with final clinical outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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
1
diffusion MRI
Radiation: diffusion MRI
diffusion MRI
2
BOLD MRI
Radiation: BOLD MRI
BOLD MRI
3
MR spectroscopy
Radiation: MR spectroscopy
MR spectroscopy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Minimum age 16 years
  • Male or female
  • Signed consensus report to the study

Exclusion Criteria:

  • History of allergy to contrast media
  • Pregnancy
  • 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
  • Back or other problems that don't allow motionless lying for 75 minutes
  • Missing signed consensus report to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575432

Contacts
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

Locations
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            
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Harriet C Thoeny, MD Institute of Radiology, University of Bern
Principal Investigator: Peter Vermathen, PhD University Bern, Dept.Clinical Research
  More Information

No publications provided

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

Keywords provided by University Hospital Inselspital, Berne:
magnetic resonance imaging
renal function
renal transplant
urinary calculi
healthy controls
kidney

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Healthy
Kidney Diseases
Calculi

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Urinary Calculi
Urologic Diseases
Urolithiasis
Calculi

ClinicalTrials.gov processed this record on September 11, 2009