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Status unknownNCT00575432Updated Nov 14, 2022

Evaluation of Kidney Function by Multi-modal Magnetic Resonance Imaging and Spectroscopy

An observational study in Kidney Transplantation and Urinary Calculi, sponsored by Insel Gruppe AG, University Hospital Bern. Status unknown at 1 site in Switzerland. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
16 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Kidney Transplantation
  • Urinary Calculi

Keywords

  • magnetic resonance imaging
  • renal function
  • renal transplant
  • urinary calculi
  • healthy controls
  • kidney
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In context

Urinary Calculi

159 studies on the registry are indexed under Urinary Calculi; 29 are open to participants now.

This study's enrollment of 200 is close to the median of 200 across 46 observational studies indexed under Urinary Calculi.

Browse Urinary Calculi studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with Kidney diseases and Renal Allografts

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    Radiation: diffusion MRI · Radiation: BOLD MRI · Other: Clinical Outcome

Interventions

  • Radiationdiffusion MRI

    diffusion MRI

  • RadiationBOLD MRI

    BOLD MRI

  • OtherClinical Outcome

    Clinical outcome

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What researchers measure

Primary outcomes

  1. Correlation of functional MR parameters with histology results as "gold standard" or with final clinical outcome

    Time frame: 6 months

Secondary outcomes

  1. 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

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Study locations

1 site
  • Department of Diagnostic and Interventional Neuroradiology
    Bern, 3010, Switzerland
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References and documents

Publications

  • 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. PubMed 34447762 ↗
  • 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. PubMed 35743353 ↗
  • 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. PubMed 24582541 ↗
  • 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. PubMed 24475796 ↗
  • 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. PubMed 20432350 ↗
  • 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. PubMed 20013274 ↗
  • 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. PubMed 18403623 ↗
  • 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. PubMed 17114628 ↗
  • 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. PubMed 19567650 ↗
  • 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. PubMed 24962556 ↗
  • 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. PubMed 26744926 ↗
  • 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. PubMed 26871263 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00575432
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Dec 18, 2007
Start date
Nov 2004
Primary completion
Dec 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Nov 14, 2022

Study contacts

Harriet C Thoeny, MD
principal investigator · Institute of Radiology, University of Bern
Peter Vermathen, PhD
principal investigator · University Bern, Dept.Clinical Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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