Assessment of Renal Function by Multiparametric MRI
Phase: EARLY_PHASE1
Conditions: Renal Impairment
Sponsor: University of Zurich

Study: Assessment of renal function by multiparametric MRI 
NCT Number: NCT06407375 
Date: June 9, 2023 
 
 

Sponsor / 
Sponsor-
Investigator 
PD Dr. med. Andreas Hötker 
University Hospital of Zurich 
CH-8091 Zürich 
E-mail: andreas.hoetker@usz.ch 
Study Title 
Assessment of renal function by multiparametric MRI/ BASEC 
00913
-
2023
 
Short Title / 
Study ID 
Renal function and multiparametric MRI 
Study 
Category and 
Rationale 
Study category B. The study includes mostly approved MRI sequences, except for an ASL 
sequence that is a work in progress (WIP)-sequence but has undergone manufacturer's quality 
assurance and has been used in other studies without issues. 
Background 
and Rationale  
The kidneys play a central role in maintaining systemic homeostasis through regulation of 
electrolyte balance, fluid distribution, and removal of metabolic waste. Despite their functional 
reserve, renal physiology undergoes gradual decline with advancing age, even in the absence 
of overt kidney disease. These structural changes are accompanied by progressive nephron 
loss, reduced renal perfusion, and impaired oxygenation, ultimately contributing to diminished 
filtration capacity. 
Traditional clinical markers of kidney function, such as serum creatinine and estimated 
glomerular filtration rate (eGFR), do not fully capture these early microstructural and 
physiological changes. Both are indirect measures influenced by multiple confounding factors 
and often remain within normal limits until significant nephron loss has occurred. This 
diagnostic delay presents a major challenge in distinguishing between normal renal aging and 
early pathological decline. In recent years, multiparametric magnetic resonance imaging 
(mpMRI) has emerged as a promising non-invasive approach to characterize renal physiology 
at a tissue level. By integrating different imaging techniques – T1, T2 and T2*-mapping, arterial 
spin labeling (ASL) and intravoxel incoherent motion mpMRI enables a more comprehensive 
evaluation of renal function than conventional methods. Standardization efforts have further 
improved its reproducibility, but the specific impact of physiological aging on renal MRI 
parameters remains insufficiently explored. 
The purpose of this study is to investigate age-related changes in renal tissue characteristics 
using multiparametric MRI in a cohort of healthy individuals and to assess the potential of these 
imaging biomarkers for differentiating physiological aging from early functional deterioration. 
Risk / Benefit 
Assessment 
Magnetic resonance imaging (MRI) is a safe imaging technique without any evidence of 
detrimental secondary effects. However, it carries a risk for individuals with metal or electronic 
implants and may cause discomfort, particularly for claustrophobic individuals. This study 
design does not offer any direct benefits to the participants but may benefit future participants 
by facilitating earlier detection of renal function impairment and a more customized therapy 
regimen. 
Objective(s) 
This study is a prospective, exploratory, single-center trial aiming on the exploration of the value 
of mpMRI in the assessment of renal function.  
The primary null hypothesis proposes no correlation between serum creatinine/eGFR values 
and MRI parameters, while the alternative hypothesis suggests a significant correlation.  
o 
The first sub-aim is to assess kidney function with mpMRI across age groups,  
o 
The second sub-aim is to compare mpMRI parameters between healthy participants 
and their age-matched metabolic syndrome group, and  
o 
The third sub-aim is to assess intra- and inter-reader variability. 
Endpoint(s) 
Primary endpoint: 
• 
1st aim: Exploration of the value of mpMRI in the assessment of renal function with 
serum creatinine and eGFR as the gold standard for comparison.  
Secondary endpoints: 
• 
1st sub-aim: Comparison across the defined age groups. 
• 
2nd sub-aim: Assessment of intra- and inter-reader variability of MRI parameters. 
Study Design 
Open label, non-randomised study  
Statistical 
Considerations 
The study aims to enroll 60 healthy participants, with 20 participants per age group (20-40a, 40-
60a and > 65a). Multiple MRI parameters will be used to describe the kidney's functional 
aspects, and statistical comparisons will be performed using t-tests, ANOVA as well as 
correlation coefficients and a multivariable ANOVA test. The data will be presented using 
histograms and box plots. Measures of intra- and inter-reader agreement will be used to assess 
differences between different readers. All primary analyses will be performed with the full 
analysis set. 

Inclusion- / 
Exclusion 
Criteria 
To be eligible for participation, subjects must meet the following inclusion criteria:  
- 
Informed consent as documented by the signature (Informed Consent Form) 
- 
participants ≥18 years of age 
- 
participants must refrain from consuming food or beverages for three hours before 
the MRI 
The presence of any of the following exclusion criteria will lead to exclusion of the participants: 
o 
Women who are pregnant or breast feeding 
o 
Intention to become pregnant during the course of the study and lack of safe 
contraception 
o 
inability to follow the procedures of the study, e.g., due to language problems, 
psychological disorders, dementia, etc. of the participant. 
o 
enrolment of the investigator, his/her family members, and other dependent 
persons 
o 
participants with non-MRI compatible metallic or electronic implants, devices, or 
metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, 
neurostimulator, or other non-MRI compatible implants). 
o 
history of hypertension 
o 
history of renal disease as indicated by a normal Quick-Serum-Creatinine level of 
less than 105 μmol/l 
Number of 
Participants 
with Rationale 
We plan to recruit 60 participants (20 participants of each age group) to allow for a sufficient 
cohort size for statistical analysis. 
Study 
Intervention 
• 
Capillary blood draw 
• 
MRI without contrast agent 20-30 minutes 
Control 
Intervention 
/  
Study 
procedures 
The participants will fast (no food or drinks for 3 hours) and undergo a multiparametric MRI 
examination prior to a capillary blood draw (if no recent (<1 week) blood sample is available in 
their medical record). MRI parameters will then be examined by two readers and statistical 
analysis will be conducted.   
Study 
Center(s) 
University of Zurich Hospital 
Data privacy 
The project data will be handled with utmost discretion and access will only be given to 
authorized personnel. Participants will be identified by a unique participant number, and MRI 
scans will be saved using a pseudonymized identifier. The study data will be stored on 
password-secured computers and servers for a minimum of 10 years after study termination, 
and periodic sampling and quality control will be performed. The study-related clinical data will 
be stored on a password-protected share, accessible only to dedicated users within the 
University Hospital Zurich network, and the key to translating the pseudonymized participant 
identifier to the real participant's name will be kept at the local study center. 
Ethical 
consideration 
This study aims to investigate the efficacy of different MRI techniques for assessing renal function 
in healthy individuals. The results may provide valuable insights into the diagnosis and treatment 
of age-related kidney diseases. Participants will be fully informed about the trial's purpose, 
procedures, potential risks and benefits, and any other relevant details that may affect their 
decision to participate. Incidental findings will be reported unless participants opt out beforehand. 
GCP Statement 
This study will be conducted in compliance with the protocol, the current version of the 
Declaration of Helsinki, the ICH-GCP, the HRA as well as other locally relevant legal and 
regulatory requirements.