Clinical trial NCT05229263: Multiparametric MRI in Healthy Volunteers and CKD Patients
Official title: Exploratory Multicentre Clinical Study to Assess Repeatibility, Reproducibility, Acceptability and Clinical Validity of Multiparametric Renal Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Healthy
Keywords: Multiparametric MRI
Chronic kidney disease
Standardization
Clinical validity
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Clinica Universidad de Navarra, Universidad de Navarra
name: Aarhus University Hospital
name: Heidelberg University
First posted: 2022-02-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of subjects (healthy volunteers and CKD patients) are involved in the study and will follow separate workflows.
Primary purpose: DIAGNOSTIC

Brief summary: Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population.

The majority of the people with CKD aren't aware and there are not available tools for early CKD detection and for an accurate prediction on these patients. Many CKD patients exhibit progressive renal dysfunction, demonstrating a failure of current, non-specific therapeutic strategies. Better methods are urgently needed for i) early diagnosis of CKD, and prediction of its progression for improved stratification of patients and better targeting of current treatments; and ii) to directly assess structural and functional responses of the kidney to new therapies and identify those patients who respond.

Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising technique for improved understanding and characterisation of renal pathophysiology. Compared to histopathology, MRI is non-invasive and avoids sampling bias by characterising the entire kidney with high spatial resolution.

In spite of a number of single centre studies showing renal MRI feasibility and potential to address a number of key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Standardization of acquisition and processing protocols across centres is therefore needed, and this will also lead to the possibility to provide preliminary data of the multiparametric renal MRI clinical validity and utility.

The purpose of this study is to standardize, assess the feasibility and provide preliminary evidence of clinical validity and utility of the multiparametric renal MRI.

To reach this goal two groups of subjects are involved:

* Group 1 (healthy volunteers). In this group the repeatibility and reproducibility of multiparametric renal MRI will be assessed.
* Group 2 (CKD patients). In this group the feasibility, the acceptability, the reproducibility and the preliminary clinical validity of multiparametric renal MRI will be assessed.


Eligibility criteria: Inclusion Criteria:

GROUP 1:

1. Provision of written informed consent prior to any study specific procedures
2. Male and female subjects aged more than18 years
3. Normotensive (office Systolic Blood Pressure values \< 140 mmHg and Diastolic Blood Pressure values ≤ 90 mmHg)
4. Normal renal condition for age (established by estimating Glomerular Filtration Rate using CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration, Creatinine Equation)
5. Negative result upon urine dipstick testing for haematuria or proteinuria.
6. Normal Urine Albumin-to-Creatinine Ratio (UACR) (\<30 mg/g)

GROUP 2:

1. Provision of written informed consent prior to any study specific procedures
2. Male and female patients aged more than18 years
3. CKD stage 2 or 3, with albuminuria up to 2000 mg

Exclusion Criteria:

GROUP 1 and 2

1. Previous enrollment in the present study
2. Contraindications to MRI including due to:

   * Claustrophobia
   * Pregnancy
   * Cardiac pacemakers or other MRI-incompatible prostheses

Only GROUP 2:

1. Urine Albumin-to-Creatinine Ratio higher than 2000 mg/g or 24h urine total albumin \>2 g
2. Polycystic kidney disease, renovascular disease, active/current nephrotic syndrome, reflux nephropathy and known congenital renal diseases or solitary kidney.
3. Active malignancy or acute or chronic inflammatory disease, HIV
4. Acute kidney injury, as defined by the the KDIGO guidelines, during the last three months.
5. Need of a new immunosuppressive therapy for treating renal disease relapse in the preceding three months.
6. Dialysis or kidney transplantation
7. CKD stages 4 or 5
8. New medication in the preceding two weeks (diuretic, hypertensive, SGLT2 treatment)

Primary outcomes:
measure: GROUP 1: within subject total kidney volume coefficient of variation in few hour time
timeFrame: At day 0
measure: GROUP 1: within subject total kidney volume coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 1: within subject renal artery blood flow coefficient of variation in few hour time
timeFrame: At day 0
measure: GROUP 1: within subject renal artery blood flow coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 1: within subject cortical perfusion coefficient of variation in few hour time
timeFrame: At day 0
measure: GROUP 1: within subject cortical perfusion coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 1: within subject cortical and medullary T1 coefficient of variation in few hour time
timeFrame: At day 0
measure: GROUP 1: within subject cortical and medullary T1 coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 1: within subject cortical and medullary T2 coefficient of variation in few hour time
timeFrame: At day 0
measure: GROUP 1: within subject cortical and medullary T2 coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 1: within subject cortical and medullary R2* coefficient of variation in few hour time
timeFrame: At day 0
measure: GROUP 1: within subject cortical and medullary R2* coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 1: within subject cortical and medullary ADC coefficient of variation in few hour time
timeFrame: At day 0
measure: GROUP 1: within subject cortical and medullary ADC coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - Percentage of complete renal MRI data collection and analysis
timeFrame: At day 0
Secondary outcomes:
measure: GROUP 1 - within subject renal total kidney volume coefficient of variation in few hour time by gender
timeFrame: At day 0
measure: GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by gender
timeFrame: At day 0
measure: GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by gender
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by gender
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by gender
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by gender
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by gender
timeFrame: At day 0
measure: GROUP 1 - within subject total kidney volume coefficient of variation in few hour time by age
timeFrame: At day 0
measure: GROUP 1 - within subject renal artery blood flow coefficient of variation in few hour time by age
timeFrame: At day 0
measure: GROUP 1 - within subject cortical perfusion coefficient of variation in few hour time by age
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary T1 coefficient of variation in few hour time by age
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary T2 coefficient of variation in few hour time by age
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary R2* coefficient of variation in few hour time by age
timeFrame: At day 0
measure: GROUP 1 - within subject cortical and medullary ADC coefficient of variation in few hour time by age
timeFrame: At day 0
measure: GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by gender
timeFrame: At day 7-14
measure: GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by gender
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by gender
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by gender
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by gender
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by gender
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by gender
timeFrame: At day 7-14
measure: GROUP 1 - within subject total kidney volume coefficient of variation after 1-2 weeks by age
timeFrame: At day 7-14
measure: GROUP 1 - within subject renal artery blood flow coefficient of variation after 1-2 weeks by age
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical perfusion coefficient of variation after 1-2 weeks by age
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks by age
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks by age
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks by age
timeFrame: At day 7-14
measure: GROUP 1 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks by age
timeFrame: At day 7-14
measure: GROUP 1 - Multiparametric MRI acceptability in healthy volunteers.
timeFrame: At day 0
measure: GROUP 2 - Multiparametric MRI acceptability in CKD patients.
timeFrame: At day 0
measure: GROUP 2 - within subject total kidney volume coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - within subject renal artery blood flow coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - within subject cortical perfusion coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - within subject cortical and medullary T1 coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - within subject cortical and medullary T2 coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - within subject cortical and medullary R2* coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - within subject cortical and medullary ADC coefficient of variation after 1-2 weeks
timeFrame: At day 7-14
measure: GROUP 2 - Correlation coefficient between MRI-based parameters and eGFR
timeFrame: At day 0
Other outcomes:
Locations:
city: Århus N
country: Denmark
facility: Aarhus University Hospital, Department of Renal Medicine
city: Heidelberg
country: Germany
facility: University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
state: Mannheim
city: Ranica
country: Italy
facility: Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
state: BG
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Giuseppe Remuzzi, MD
role: STUDY_CHAIR
References: