Diffusion Weighted Magnetic Resonance Imaging in Chronic Kidney Disease

Renal Disease Clinical Trial

Official title:

Role of Diffusion Weighted Magnetic Resonance Imaging in Evaluation of Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03174899
• Other study ID #: DMR
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: Ahmed Moustafa Hamed, MD
• Phone: 01000024182
• Email: moustafamanar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic kidney disease (CKD) is a common global public health problem and the average incidence of end-stage renal disease in developing countries is 150 per million population, which is lower than that in the developed world

Description:

Since renal parenchymal disease is accompanied by renal dysfunction, monitoring renal function permits assessment of disease progression, and periodic assessment of renal function is necessary for optimal management of a patient with suspected/proven renal disease. Serum creatinine (S Cr), blood urea (BU), and estimated glomerular filtration rate (eGFR) derived from creatinine clearance are useful for monitoring renal function; however, these indirect measures of renal filtration are imperfect and cannot assess single kidney function.

Keeping in view the limitations of serum markers, imaging may play an important role in the evaluation of renal parenchymal disease. Ultrasonography (US) and computed tomographic (CT) scan provide good anatomic images but limited functional information. Although US may show changes in renal echogenicity, it suffers from operator dependency and lacks objectivity. In addition to exposure to ionizing radiation, computed tomography (CT) scan requires use of iodinated contrast material, which is undesirable in patients with renal dysfunction. Magnetic resonance imaging (MRI) has the unique ability to show both structure and function objectively without any radiation exposure to the patient. Functional MRI techniques such as diffusion-weighted imaging (DWI), blood oxygen level-dependent (BOLD) imaging have potential utility in the evaluation of renal function .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: August 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients in different age and sex groups with CKD detected by clinical and laboratory examination.

Exclusion Criteria:

• Patients with any general contraindication to MRI as presence of any paramagnetic substance as pacemakers or in severely ill patients or those with claustrophobia and arrhythmic patients.

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Disease
• Renal Insufficiency, Chronic

Intervention

Radiation:
• Diffusion weighted magnetic resonance imaging
All MRI examinations will be performed with a 1.5-T scanner (Acheiva, Philips, and Netherland). All MRI scans will be obtained with the following parameters: Repetition time (TR); 1580 MS, echo time (TE); 60 MS, slice thickness; 1-5 mm, receiver bandwidth; 1158 kHz/pixel, field of view (FOV); 40 cm, matrix size; 164 × 159. ADC value of the kidneys will be calculated with Diffusion weighted magnetic resonance imaging gradient b-values of 0 and 1000s/mm2. In the axial ADC map, a region of interest (ROI) will be placed for measurement of ADC values on the renal parenchyma of both kidneys, without any preference for cortex or medulla. Three circular ROIs of size 1 cm2 will be placed-one each at the upper pole, inter-polar region, and lower pole of both kidneys—and 6 total ROIs from bilateral kidneys will be averaged for each patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Prigent A. Monitoring renal function and limitations of renal function tests. Semin Nucl Med. 2008 Jan;38(1):32-46. Review. — View Citation

Squillaci E, Manenti G, Di Stefano F, Miano R, Strigari L, Simonetti G. Diffusion-weighted MR imaging in the evaluation of renal tumours. J Exp Clin Cancer Res. 2004 Mar;23(1):39-45. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation apparent diffusion coefficient(ADC)of the kidneys for 31 patient with chronic kidney disease by diffusion gradient 0_1000s/mm2	In the axial apparent diffusion coefficient(ADC )map, a region of interest (ROI) will be placed for measurement of ADC values on the renal parenchyma of both kidneys, without any preference for cortex or medulla. Three circular ROIs of size 1 cm2 will be placed-one each at the upper pole, inter-polar region, and lower pole of both kidneys—and 6 total ROIs from bilateral kidneys will be averaged for each patient. The mean ADC values will be recorded for each patient and the relationship of ADC values of different stages of CKD and its relationship with serum markers of renal function will be evaluated.	up to 24hour