Diffusion Weighted Magnetic Resonance Imaging in Chronic Kidney Disease

NCT ID: NCT03174899

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-08-01

Brief 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

Detailed 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 .

Conditions

Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Stage1:eGFR; ≥90 mL/min/1.73 m2 .

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. The mean ADC values will be recorded for each patient and the relationship of ADC values with CKD stage will be evaluated.

Group Type: EXPERIMENTAL

Diffusion weighted magnetic resonance imaging

Intervention Type: RADIATION

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.

Stage 2: eGFR; 60-89 mL/min/1.73 m2 .

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. The mean ADC values will be recorded for each patient and the relationship of ADC values with CKD stage will be evaluated.

Group Type: EXPERIMENTAL

Diffusion weighted magnetic resonance imaging

Intervention Type: RADIATION

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.

Stage 3:eGFR; 30-59 mL/min/1.73 m2

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. The mean ADC values will be recorded for each patient and the relationship of ADC values with CKD stage will be evaluated.

Group Type: EXPERIMENTAL

Diffusion weighted magnetic resonance imaging

Intervention Type: RADIATION

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.

Stage 4:eGFR; 15-29 mL/min/1.73 m2 .

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 imaginggradient 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. The mean ADC values will be recorded for each patient and the relationship of ADC values with CKD stage will be evaluated.

Group Type: EXPERIMENTAL

Diffusion weighted magnetic resonance imaging

Intervention Type: RADIATION

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.

Stage 5:eGFR; < 15 mL/min/1.73 m2.

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. The mean ADC values will be recorded for each patient and the relationship of ADC values with CKD stage will be evaluated.

Group Type: EXPERIMENTAL

Diffusion weighted magnetic resonance imaging

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

DMAhmed

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Moustafa Hamed, MD

Role: CONTACT

moustafamanar@gmail.com

01000024182

Nisreen adel abbas mohammed, MD

Role: CONTACT

Nisreen10@ymail.com

01229199971

References

Prigent A. Monitoring renal function and limitations of renal function tests. Semin Nucl Med. 2008 Jan;38(1):32-46. doi: 10.1053/j.semnuclmed.2007.09.003.

Reference Type: BACKGROUND

PMID: 18096462 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15149149 (View on PubMed)

Other Identifiers

DMR

Identifier Type: -

Identifier Source: org_study_id