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

Kidney Transplantation Clinical Trial

Official title:

Evaluation of Kidney Function by Multi-modal Magnetic Resonance Imaging and Spectroscopy in Renal Transplantation and Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00575432
• Other study ID #: KEK 213/04
• Secondary ID: 1066
• Status: Active, not recruiting
• Start date: November 2004
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Kidney Transplantation
• Urinary Calculi
• Urolithiasis

Intervention

Radiation:
• diffusion MRI
diffusion MRI
• BOLD MRI
BOLD MRI

Other:
• Clinical Outcome
Clinical outcome

Locations

Country	Name	City	State
Switzerland	Department of Diagnostic and Interventional Neuroradiology	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

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. — View 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/rad — View 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 2 — View 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. — View 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). pii: 3284. doi: 10.3390/jcm11123284. — View 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. — View 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/radi — View 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 20 — View 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 — View 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. — View 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; — View 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): — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of functional MR parameters with histology results as "gold standard" or with final clinical outcome		6 months
Secondary	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)		6 months