Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners

Reproducibility of Multiparametric Renal Magnetic Resonance Imaging on 1.5T MRI Scanners (RESPECT_1.5T Sub-study)

This is an interventional, multicenter, prospective study involving healthy volunteers, to primarily assess the reproducibility of multiparametric renal MRI on 1.5T scanners. The study is also aimed at assessing possible differences in renal MRI reproducibility on 1.5T MRI scanners by sex and age, and assessing possible differences in renal MRI reproducibility across field strengths (1.5T vs 3T) in the subgroup of subjects enrolled in both RESPECT clinical study and in the current subproject.

Study Overview

• Status: Recruiting
• Conditions: Multiparametric MRI
• Intervention / Treatment: Device: MRI

Detailed Description

Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising non-invasive technique for improved understanding and characterisation of renal pathophysiology.

Despite renal MRI potential to address several key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Widely accepted normative values of renal MRI measures to establish benchmarks for early diagnosis, prognosis or treatment planning are not available. Standardization of acquisition and processing protocols across centres is therefore needed, and this is a necessary preliminary step towards multiparametric renal MRI wider use in clinical research and ultimate adoption in clinical practice.

The ongoing "Exploratory multicentre clinical study to assess repeatability, reproducibility, acceptability and clinical validity of multiparametric renal Magnetic Resonance Imaging (RESPECT Trial, NCT05229263)" trial will provide relevant information on repeatability and reproducibility of MRI measures obtained from multiparametric MRI scans acquired on 3T scanners, that represent the state-of-the-art for clinical research. However, 3T MRI scanners are not available in most clinical centres, where instead lower-field (1.5T) MRI scanners are much more common. Investigating reproducibility of renal MRI measures on 1.5T scanners and assessing possible differences in reproducibility across magnetic field strength would be needed towards translation of the results of the RESPECT clinical study to clinics.

The possible advantages that can derive from participating in the present research are essentially linked to the possibility to specifically assess the renal function with multiparametric MRI, that is not part of the routine clinical practice. More generally, in the long term, it will be possible for CKD patients to benefit from the results of this study that is aimed at demonstrating the reproducibility and the clinical validity of multiparametric MRI.

Participation in the study will not entail any additional risk to subjects' health. All clinical MRI safety procedures will be strictly followed. Indeed, multiparametric MRI acquisitions required by this research will be performed without the administration of contrast media and do not present risks in either short or long term.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matias Trillini, M.D.; Phone Number: +390354535411; Email: matias.trillini@marionegri.it

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Not yet recruiting
    • Aarhus University Hospital
    • Contact: Niels H Buus, M.D.; Phone Number: +4530313404; Email: nhb@biomed.au.dk
    • Principal Investigator: Niels H Buus, M.D.
• Germany
  • Mannheim, Germany, 68197
    • Not yet recruiting
    • University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University
    • Contact: Dominik Nörenberg, MHBA; Phone Number: +4906213832067; Email: Dominik.Noerenberg@medma.uni-heidelberg.de
    • Principal Investigator: Dominik Nörenberg, MHBA
• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Matteo Renzulli, M.D.; Phone Number: +390512141228; Email: matteo.renzulli@aosp.bo.it
      • Principal Investigator: Matteo Renzulli, M.D.
• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Not yet recruiting
      • Clinica Universidad de Navarra
      • Contact: Nuria G Fernandez, M.D.; Phone Number: +34948255400; Email: nrgarcia@unav.es
      • Principal Investigator: Nuria G Fernandez, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provision of written informed consent prior to any study specific procedures
• Male and female subjects aged [18-70] years
• Office SBP values < 140 mmHg and DBP values ≤ 90 mmHg, under no antihypertensive therapy
• Normal renal function defined as: estimated glomerular filtration rate [eGFR] ≥ 60mL/min/1.73m2 (using CKD-EPI Creatinine Equation)
• Negative result upon urine testing for haematuria or proteinuria.

Exclusion Criteria:

• Previous enrollment in the present substudy
• Contraindications to MRI including caustrophobia, pregnancy, cardiac pacemakers or other MRI-incompatible prostheses
• Ongoing therapy (e.g. for diabetes, dyslipidemia, or any acute disease)
• Past or current oncological pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteers; Healthy volunteers selected from 4 different centers. Each center will recruit 6 males and 6 females each.	Device: MRI; Multiparametric renal MRI on 1.5T scanners

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumes	Total kidney, cortical and medullary volumes (in mL)	At day 0 and from 7 to 14 days after
Oxygenation	Renal tissue oxygenation obtained by measuring the R2* relaxation rate (in 1/ms)	At day 0 and from 7 to 14 days after
Diffusion coefficient	Apparent diffusion coefficient (in cm2/s)	At day 0 and from 7 to 14 days after
Tissue perfusion	Renal tissue perfusion (in mL/100mL/min)	At day 0 and from 7 to 14 days after
Blood flow	Renal blood flow (in mL/min)	At day 0 and from 7 to 14 days after
Relaxation times	T1 and T2 relaxation times (in ms)	At day 0 and from 7 to 14 days after

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Investigators: Principal Investigator: Giuseppe Remuzzi, M.D., Istituto Di Ricerche Farmacologiche Mario Negri

Publications and helpful links

General Publications

• Selby NM, Blankestijn PJ, Boor P, Combe C, Eckardt KU, Eikefjord E, Garcia-Fernandez N, Golay X, Gordon I, Grenier N, Hockings PD, Jensen JD, Joles JA, Kalra PA, Kramer BK, Mark PB, Mendichovszky IA, Nikolic O, Odudu A, Ong ACM, Ortiz A, Pruijm M, Remuzzi G, Rorvik J, de Seigneux S, Simms RJ, Slatinska J, Summers P, Taal MW, Thoeny HC, Vallee JP, Wolf M, Caroli A, Sourbron S. Magnetic resonance imaging biomarkers for chronic kidney disease: a position paper from the European Cooperation in Science and Technology Action PARENCHIMA. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii4-ii14. doi: 10.1093/ndt/gfy152.
• Caroli A, Pruijm M, Burnier M, Selby NM. Functional magnetic resonance imaging of the kidneys: where do we stand? The perspective of the European COST Action PARENCHIMA. Nephrol Dial Transplant. 2018 Sep 1;33(suppl_2):ii1-ii3. doi: 10.1093/ndt/gfy181. No abstract available.
• McAlinden C, Khadka J, Pesudovs K. Precision (repeatability and reproducibility) studies and sample-size calculation. J Cataract Refract Surg. 2015 Dec;41(12):2598-604. doi: 10.1016/j.jcrs.2015.06.029. No abstract available.
• Xie L, Bennett KM, Liu C, Johnson GA, Zhang JL, Lee VS. MRI tools for assessment of microstructure and nephron function of the kidney. Am J Physiol Renal Physiol. 2016 Dec 1;311(6):F1109-F1124. doi: 10.1152/ajprenal.00134.2016. Epub 2016 Sep 14.
• Grenier N, Merville P, Combe C. Radiologic imaging of the renal parenchyma structure and function. Nat Rev Nephrol. 2016 Jun;12(6):348-59. doi: 10.1038/nrneph.2016.44. Epub 2016 Apr 12.
• Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: kidney; reproducibility; multiparametric MRI; standardization; MRI scanners
• Other Study ID Numbers: RESPECT_1.5T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No