Diffusion Weighted Magnetic Resonance Imaging in Chronic Kidney Disease

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Diffusion weighted magnetic resonance imaging

About this trial

This is an interventional diagnostic trial for Renal Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Stage1:eGFR; ≥90 mL/min/1.73 m2 .

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

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

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

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

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03174899

First Posted

May 26, 2017

Last Updated

July 6, 2018

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03174899

Brief Title

Diffusion Weighted Magnetic Resonance Imaging in Chronic Kidney Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2018 (Anticipated)

Primary Completion Date

April 1, 2019 (Anticipated)

Study Completion Date

August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stage1:eGFR; ≥90 mL/min/1.73 m2 .

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Diffusion weighted magnetic resonance imaging

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluation apparent diffusion coefficient(ADC)of the kidneys for 31 patient with chronic kidney disease by diffusion gradient 0_1000s/mm2

Description

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.

Time Frame

up to 24hour

10. Eligibility

Sex

All

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Moustafa Hamed, MD

Phone

01000024182

Email

moustafamanar@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nisreen adel abbas mohammed, MD

Phone

01229199971

Email

Nisreen10@ymail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

18096462

Citation

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.

Results Reference

background

PubMed Identifier

15149149

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.

Results Reference

background

Renal Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial