Renal DiseaseNCT03174899
Diffusion Weighted Magnetic Resonance Imaging in Chronic Kidney Disease
A study testing Diffusion weighted magnetic resonance imaging in people with Renal Disease, run by Assiut University.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Disease
- What is being tested?
- Diffusion weighted magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in different age and sex groups with CKD detected by clinical and laboratory examination.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Diffusion Weighted Magnetic Resonance Imaging in Evaluation of Chronic Kidney Disease
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
Read the 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
- Being tested
- Diffusion weighted magnetic resonance imaging
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion weighted magnetic resonance imagingRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage1:eGFR; ≥90 mL/min/1.73 m2 . | Experimental | 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. Receives: Radiation: Diffusion weighted magnetic resonance imaging |
| Stage 2: eGFR; 60-89 mL/min/1.73 m2 . | Experimental | 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. Receives: Radiation: Diffusion weighted magnetic resonance imaging |
| Stage 3:eGFR; 30-59 mL/min/1.73 m2 | Experimental | 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. Receives: Radiation: Diffusion weighted magnetic resonance imaging |
| Stage 4:eGFR; 15-29 mL/min/1.73 m2 . | Experimental | 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. Receives: Radiation: Diffusion weighted magnetic resonance imaging |
| Stage 5:eGFR; < 15 mL/min/1.73 m2. | Experimental | 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. Receives: Radiation: Diffusion weighted magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start1 Jul 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DMAhmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174899
- Sponsor's protocol ID
- DMR
- Status last verified
- Jul 2018
- First submitted
- 26 May 2017
- Last updated
- 10 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18096462Squillaci 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.
PubMed 15149149
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Diffusion Weighted Magnetic Resonance Imaging in Evaluation of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03174899
- Acronym / sponsor ID
- DMR
- Conditions
- Renal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage1:eGFR; ≥90 mL/min/1.73 m2 . | Experimental | Radiation: Diffusion weighted magnetic resonance imagingAll 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. |
| Stage 2: eGFR; 60-89 mL/min/1.73 m2 . | Experimental | Radiation: Diffusion weighted magnetic resonance imagingAll 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. |
| Stage 3:eGFR; 30-59 mL/min/1.73 m2 | Experimental | Radiation: Diffusion weighted magnetic resonance imagingAll 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. |
| Stage 4:eGFR; 15-29 mL/min/1.73 m2 . | Experimental | Radiation: Diffusion weighted magnetic resonance imagingAll 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. |
| Stage 5:eGFR; < 15 mL/min/1.73 m2. | Experimental | Radiation: Diffusion weighted magnetic resonance imagingAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in different age and sex groups with CKD detected by clinical and laboratory examination.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion weighted magnetic resonance imagingAll 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. | Radiation | 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., Stage1:eGFR; ≥90 mL/min/1.73 m2 . |
Primary outcome
Evaluation apparent diffusion coefficient(ADC)of the kidneys for 31 patient with chronic kidney disease by diffusion gradient 0_1000s/mm2
Time frame: up to 24hour
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Background: PubMed 18096462Prigent 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.
- Background: PubMed 15149149Squillaci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion weighted magnetic resonance imaging in people with Renal Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Moustafa Hamed, MD (01000024182, moustafamanar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation apparent diffusion coefficient(ADC)of the kidneys for 31 patient with chronic kidney disease by diffusion gradient 0_1000s/mm2 (time frame: up to 24hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174899, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018; AzTrials last refreshed its copy on 31 Oct 2026.