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

November 9, 2022 updated by: University Hospital Inselspital, Berne

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Diagnostic and Interventional Neuroradiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Kidney diseases and Renal Allografts

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Radiation: diffusion MRI
diffusion MRI
Radiation: BOLD MRI
BOLD MRI
Other: Clinical Outcome
Clinical outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of functional MR parameters with histology results as "gold standard" or with final clinical outcome
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (ESTIMATE)

December 18, 2007

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK 213/04
  • 1066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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