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

Sponsor

University Hospital Inselspital, Berne (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00575432

Collaborator

(none)

200

Enrollment

Location

229

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Urinary Calculi	Radiation: diffusion MRI Radiation: BOLD MRI Other: Clinical Outcome

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 Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Correlation of functional MR parameters with histology results as "gold standard" or with final clinical outcome [6 months]

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) [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Urology	Bern		Switzerland	3010

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